GSK plc (GSK)
FDA Applications
Note: This list only includes applications that have been responded to by the FDA.
Application | Product Name | Active Ingredient | Form | Strength | Status | ||
---|---|---|---|---|---|---|---|
BLA761223 - GLAXOSMITHKLINE LLC | |||||||
JEMPERLI | DOSTARLIMAB-GXLY | INJECTABLE;INJECTION | 500MG/10ML | Prescription | |||
BLA761174 - GLAXOSMITHKLINE | |||||||
JEMPERLI | DOSTARLIMAB-GXLY | INJECTABLE;INJECTION | 500MG/10ML | Prescription | |||
BLA761122 - GLAXOSMITHKLINE | |||||||
NUCALA | MEPOLIZUMAB | INJECTABLE;SUBCUTANEOUS | 100MG/ML | Prescription | |||
BLA761043 - GLAXOSMITHKLINE LLC | |||||||
BENLYSTA | BELIMUMAB | INJECTABLE;INJECTION | 200MG/ML | Prescription | |||
NDA216951 - GLAXOSMITHKLINE | |||||||
JESDUVROQ | DAPRODUSTAT | TABLET;ORAL | 1MG | Discontinued | |||
JESDUVROQ | DAPRODUSTAT | TABLET;ORAL | 2MG | Discontinued | |||
JESDUVROQ | DAPRODUSTAT | TABLET;ORAL | 4MG | Discontinued | |||
JESDUVROQ | DAPRODUSTAT | TABLET;ORAL | 6MG | Discontinued | |||
JESDUVROQ | DAPRODUSTAT | TABLET;ORAL | 8MG | Discontinued | |||
NDA216873 - GLAXOSMITHKLINE | |||||||
OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | Prescription | |||
OJJAARA | MOMELOTINIB DIHYDROCHLORIDE | TABLET;ORAL | EQ 200MG BASE | Prescription | |||
NDA214876 - GLAXOSMITHKLINE | |||||||
ZEJULA | NIRAPARIB TOSYLATE | TABLET;ORAL | EQ 200MG BASE | Prescription | |||
ZEJULA | NIRAPARIB TOSYLATE | TABLET;ORAL | EQ 300MG BASE | Prescription | |||
ZEJULA | NIRAPARIB TOSYLATE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
NDA210795 - GLAXOSMITHKLINE | |||||||
KRINTAFEL | TAFENOQUINE SUCCINATE | TABLET;ORAL | EQ 150MG BASE | Prescription | |||
NDA209482 - GLAXOSMITHKLINE | |||||||
TRELEGY ELLIPTA | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | POWDER;INHALATION | 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | Prescription | |||
TRELEGY ELLIPTA | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | POWDER;INHALATION | 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | Prescription | |||
NDA208447 - GLAXOSMITHKLINE | |||||||
ZEJULA | NIRAPARIB TOSYLATE | CAPSULE;ORAL | EQ 100MG BASE | Discontinued | |||
NDA205625 - GLAXOSMITHKLINE | |||||||
ARNUITY ELLIPTA | FLUTICASONE FUROATE | POWDER;INHALATION | 0.2MG/INH | Prescription | |||
ARNUITY ELLIPTA | FLUTICASONE FUROATE | POWDER;INHALATION | 0.1MG/INH | Prescription | |||
ARNUITY ELLIPTA | FLUTICASONE FUROATE | POWDER;INHALATION | 0.05MG/INH | Prescription | |||
NDA205382 - GLAXO GRP ENGLAND | |||||||
INCRUSE ELLIPTA | UMECLIDINIUM BROMIDE | POWDER;INHALATION | EQ 0.0625MG BASE/INH | Prescription | |||
NDA204275 - GLAXO GRP LTD | |||||||
BREO ELLIPTA | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | POWDER;INHALATION | 0.2MG/INH;EQ 0.025MG BASE/INH | Prescription | |||
BREO ELLIPTA | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | POWDER;INHALATION | 0.05MG/INH;EQ 0.025MG BASE/INH | Prescription | |||
BREO ELLIPTA | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | POWDER;INHALATION | 0.1MG/INH;EQ 0.025MG BASE/INH | Prescription | |||
NDA203975 - GLAXOSMITHKLINE | |||||||
ANORO ELLIPTA | UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | POWDER;INHALATION | EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | Prescription | |||
BLA125526 - GLAXOSMITHKLINE LLC | |||||||
NUCALA | MEPOLIZUMAB | INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER | 100MG | Prescription | |||
BLA125431 - GLAXOSMITHKLINE LLC | |||||||
TANZEUM | ALBIGLUTIDE | INJECTABLE;INJECTION | 30MG | Discontinued | |||
ANDA089834 - GLAXOSMITHKLINE | |||||||
WELLCOVORIN | LEUCOVORIN CALCIUM | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL | Discontinued | |||
ANDA089833 - GLAXOSMITHKLINE | |||||||
WELLCOVORIN | LEUCOVORIN CALCIUM | INJECTABLE;INJECTION | EQ 25MG BASE/VIAL | Discontinued | |||
ANDA089465 - GLAXOSMITHKLINE | |||||||
WELLCOVORIN | LEUCOVORIN CALCIUM | INJECTABLE;INJECTION | EQ 50MG BASE/VIAL | Discontinued | |||
ANDA087439 - GLAXOSMITHKLINE | |||||||
WELLCOVORIN | LEUCOVORIN CALCIUM | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | EQ 5MG BASE/ML (EQ 5MG BASE/ML) | Discontinued | |||
WELLCOVORIN | LEUCOVORIN CALCIUM | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | Discontinued | |||
ANDA084935 - GLAXOSMITHKLINE | |||||||
DEXEDRINE | DEXTROAMPHETAMINE SULFATE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANDA084060 - GLAXOSMITHKLINE | |||||||
PHYTONADIONE | PHYTONADIONE | INJECTABLE;INJECTION | 1MG/0.5ML | Discontinued | |||
PHYTONADIONE | PHYTONADIONE | INJECTABLE;INJECTION | 10MG/ML | Discontinued | |||
ANDA083951 - GLAXOSMITHKLINE | |||||||
EMPRACET W/ CODEINE PHOSPHATE #3 | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;30MG | Discontinued | |||
EMPRACET W/ CODEINE PHOSPHATE #4 | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 300MG;60MG | Discontinued | |||
ANDA083902 - GLAXOSMITHKLINE | |||||||
DEXEDRINE | DEXTROAMPHETAMINE SULFATE | ELIXIR;ORAL | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANDA077658 - GLAXOSMITHKLINE CONS | |||||||
THRIVE | NICOTINE POLACRILEX | GUM, CHEWING;BUCCAL | EQ 2MG BASE | Discontinued | |||
ANDA077656 - GLAXOSMITHKLINE CONS | |||||||
THRIVE | NICOTINE POLACRILEX | GUM, CHEWING;BUCCAL | EQ 4MG BASE | Discontinued | |||
ANDA075822 - GLAXOSMITHKLINE | |||||||
LORATADINE | LORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | Discontinued | |||
ANDA064033 - GLAXOSMITHKLINE | |||||||
CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
ANDA064008 - GLAXOSMITHKLINE | |||||||
PENTACEF | CEFTAZIDIME | INJECTABLE;INJECTION | 10GM/VIAL | Discontinued | |||
PENTACEF | CEFTAZIDIME | INJECTABLE;INJECTION | 6GM/VIAL | Discontinued | |||
ANDA064006 - GLAXOSMITHKLINE | |||||||
PENTACEF | CEFTAZIDIME | INJECTABLE;INJECTION | 2GM/VIAL | Discontinued | |||
PENTACEF | CEFTAZIDIME | INJECTABLE;INJECTION | 1GM/VIAL | Discontinued | |||
ANDA063322 - GLAXOSMITHKLINE | |||||||
PENTACEF | CEFTAZIDIME | INJECTABLE;INJECTION | 2GM/VIAL | Discontinued | |||
PENTACEF | CEFTAZIDIME | INJECTABLE;INJECTION | 1GM/VIAL | Discontinued | |||
ANDA063295 - GLAXOSMITHKLINE | |||||||
MONOCID | CEFONICID SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
ANDA062755 - GLAXOSMITHKLINE | |||||||
NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
ANDA062736 - GLAXOSMITHKLINE | |||||||
BACTOCILL | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
BACTOCILL | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANDA062727 - GLAXOSMITHKLINE | |||||||
TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
ANDA062691 - GLAXOSMITHKLINE | |||||||
TIMENTIN | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL | Discontinued | |||
ANDA062690 - GLAXOSMITHKLINE | |||||||
TICAR | TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 3GM BASE/VIAL | Discontinued | |||
ANDA062435 - GLAXOSMITHKLINE | |||||||
SEFFIN | CEPHALOTHIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | Discontinued | |||
SEFFIN | CEPHALOTHIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
SEFFIN | CEPHALOTHIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
ANDA062321 - GLAXOSMITHKLINE | |||||||
BACTOCILL | OXACILLIN SODIUM | FOR SOLUTION;ORAL | EQ 250MG BASE/5ML | Discontinued | |||
ANDA062273 - GLAXOSMITHKLINE | |||||||
BEEPEN-VK | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 500MG BASE | Discontinued | |||
BEEPEN-VK | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 250MG BASE | Discontinued | |||
ANDA062270 - GLAXOSMITHKLINE | |||||||
BEEPEN-VK | PENICILLIN V POTASSIUM | FOR SOLUTION;ORAL | EQ 125MG BASE/5ML | Discontinued | |||
BEEPEN-VK | PENICILLIN V POTASSIUM | FOR SOLUTION;ORAL | EQ 250MG BASE/5ML | Discontinued | |||
ANDA062241 - GLAXOSMITHKLINE | |||||||
BACTOCILL | OXACILLIN SODIUM | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
BACTOCILL | OXACILLIN SODIUM | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
ANDA062238 - GLAXOSMITHKLINE | |||||||
DYCILL | DICLOXACILLIN SODIUM | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
DYCILL | DICLOXACILLIN SODIUM | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
ANDA062233 - GLAXOSMITHKLINE | |||||||
CLOXAPEN | CLOXACILLIN SODIUM | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
CLOXAPEN | CLOXACILLIN SODIUM | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
ANDA062223 - GLAXOSMITHKLINE | |||||||
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | Discontinued | |||
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | Discontinued | |||
ANDA062212 - GLAXOSMITHKLINE | |||||||
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
ANDA062036 - GLAXOSMITHKLINE | |||||||
AEROSPORIN | POLYMYXIN B SULFATE | INJECTABLE;INJECTION | EQ 500,000 UNITS BASE/VIAL | Discontinued | |||
ANDA061999 - GLAXOSMITHKLINE | |||||||
NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | Discontinued | |||
NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Discontinued | |||
NALLPEN | NAFCILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
ANDA061866 - GLAXOSMITHKLINE | |||||||
ANSPOR | CEPHRADINE | FOR SUSPENSION;ORAL | 250MG/5ML | Discontinued | |||
ANSPOR | CEPHRADINE | FOR SUSPENSION;ORAL | 125MG/5ML | Discontinued | |||
ANDA061859 - GLAXOSMITHKLINE | |||||||
ANSPOR | CEPHRADINE | CAPSULE;ORAL | 500MG | Discontinued | |||
ANSPOR | CEPHRADINE | CAPSULE;ORAL | 250MG | Discontinued | |||
ANDA061806 - GLAXOSMITHKLINE | |||||||
CLOXAPEN | CLOXACILLIN SODIUM | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
CLOXAPEN | CLOXACILLIN SODIUM | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
ANDA061336 - GLAXOSMITHKLINE | |||||||
BACTOCILL | OXACILLIN SODIUM | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
BACTOCILL | OXACILLIN SODIUM | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
ANDA061334 - GLAXOSMITHKLINE | |||||||
BACTOCILL | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
BACTOCILL | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
BACTOCILL | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
BACTOCILL | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
BACTOCILL | OXACILLIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANDA060677 - GLAXOSMITHKLINE | |||||||
TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 125MG BASE/VIAL | Discontinued | |||
TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | Discontinued | |||
TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Discontinued | |||
TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | Discontinued | |||
TOTACILLIN-N | AMPICILLIN SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
ANDA060666 - GLAXOSMITHKLINE | |||||||
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | Discontinued | |||
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | Discontinued | |||
ANDA060254 - GLAXOSMITHKLINE | |||||||
DYCILL | DICLOXACILLIN SODIUM | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
DYCILL | DICLOXACILLIN SODIUM | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
ANDA060060 - GLAXOSMITHKLINE | |||||||
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | CAPSULE;ORAL | EQ 250MG BASE | Discontinued | |||
TOTACILLIN | AMPICILLIN/AMPICILLIN TRIHYDRATE | CAPSULE;ORAL | EQ 500MG BASE | Discontinued | |||
NDA050746 - GLAXOSMITHKLINE | |||||||
BACTROBAN | MUPIROCIN CALCIUM | CREAM;TOPICAL | EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050703 - GLAXOSMITHKLINE | |||||||
BACTROBAN | MUPIROCIN CALCIUM | OINTMENT;NASAL | EQ 2% BASE | Discontinued | |||
NDA050672 - GLAXOSMITHKLINE | |||||||
CEFTIN | CEFUROXIME AXETIL | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | Discontinued | |||
CEFTIN | CEFUROXIME AXETIL | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | Discontinued | |||
NDA050658 - GLAXOSMITHKLINE | |||||||
TIMENTIN IN PLASTIC CONTAINER | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 100MG BASE/100ML;EQ 3GM BASE/100ML | Discontinued | |||
NDA050646 - GLAXOSMITHKLINE | |||||||
CEPTAZ | CEFTAZIDIME | INJECTABLE;INJECTION | 500MG/VIAL | Discontinued | |||
CEPTAZ | CEFTAZIDIME | INJECTABLE;INJECTION | 1GM/VIAL | Discontinued | |||
CEPTAZ | CEFTAZIDIME | INJECTABLE;INJECTION | 2GM/VIAL | Discontinued | |||
CEPTAZ | CEFTAZIDIME | INJECTABLE;INJECTION | 10GM/VIAL | Discontinued | |||
NDA050605 - GLAXOSMITHKLINE | |||||||
CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050591 - GLAXOSMITHKLINE | |||||||
BACTROBAN | MUPIROCIN | OINTMENT;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050590 - GLAXOSMITHKLINE | |||||||
TIMENTIN | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL | Discontinued | |||
TIMENTIN | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL | Discontinued | |||
TIMENTIN | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL | Discontinued | |||
NDA050579 - GLAXOSMITHKLINE | |||||||
MONOCID | CEFONICID SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Discontinued | |||
MONOCID | CEFONICID SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
MONOCID | CEFONICID SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
MONOCID | CEFONICID SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | Discontinued | |||
NDA050497 - GLAXOSMITHKLINE | |||||||
TICAR | TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 30GM BASE/VIAL | Discontinued | |||
TICAR | TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 20GM BASE/VIAL | Discontinued | |||
TICAR | TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 3GM BASE/VIAL | Discontinued | |||
TICAR | TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 6GM BASE/VIAL | Discontinued | |||
TICAR | TICARCILLIN DISODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
NDA050461 - GLAXOSMITHKLINE | |||||||
ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ANCEF | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050460 - GLAXOSMITHKLINE | |||||||
AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
LAROTID | AMOXICILLIN | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050459 - GLAXOSMITHKLINE | |||||||
AMOXIL | AMOXICILLIN | CAPSULE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
AMOXIL | AMOXICILLIN | CAPSULE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA050298 - GLAXOSMITHKLINE | |||||||
PYOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | Discontinued | |||
PYOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | Discontinued | |||
PYOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Discontinued | |||
PYOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | Discontinued | |||
PYOPEN | CARBENICILLIN DISODIUM | INJECTABLE;INJECTION | EQ 20GM BASE/VIAL | Discontinued | |||
NDA050176 - GLAXOSMITHKLINE | |||||||
NEOSPORIN | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | CREAM;TOPICAL | EQ 3.5MG BASE/GM;10,000 UNITS/GM | Discontinued | |||
NDA050167 - GLAXOSMITHKLINE | |||||||
POLYSPORIN | BACITRACIN ZINC; POLYMYXIN B SULFATE | AEROSOL;TOPICAL | 10,000 UNITS/GM;2,000,000 UNITS/GM | Discontinued | |||
NDA022509 - SMITHKLINE BEECHAM | |||||||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE; ORAL | 25MG | Prescription | |||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE; ORAL | 50MG | Prescription | |||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE; ORAL | 100MG | Prescription | |||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE; ORAL | 200MG | Prescription | |||
NDA022345 - GLAXOSMITHKLINE | |||||||
POTIGA | EZOGABINE | TABLET;ORAL | 200MG | Discontinued | |||
POTIGA | EZOGABINE | TABLET;ORAL | 300MG | Discontinued | |||
POTIGA | EZOGABINE | TABLET;ORAL | 50MG | Discontinued | |||
POTIGA | EZOGABINE | TABLET;ORAL | 400MG | Discontinued | |||
NDA022251 - GLAXOSMITHKLINE LLC | |||||||
LAMICTAL ODT | LAMOTRIGINE | TABLET, ORALLY DISINTEGRATING;ORAL | 50MG | Prescription | |||
LAMICTAL ODT | LAMOTRIGINE | TABLET, ORALLY DISINTEGRATING;ORAL | 100MG | Prescription | |||
LAMICTAL ODT | LAMOTRIGINE | TABLET, ORALLY DISINTEGRATING;ORAL | 200MG | Prescription | |||
LAMICTAL ODT | LAMOTRIGINE | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG | Prescription | |||
NDA022115 - GLAXOSMITHKLINE LLC | |||||||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | Prescription | |||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 300MG | Prescription | |||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 250MG | Prescription | |||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Prescription | |||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 50MG | Prescription | |||
LAMICTAL XR | LAMOTRIGINE | TABLET, EXTENDED RELEASE;ORAL | 25MG | Prescription | |||
NDA022008 - GLAXOSMITHKLINE LLC | |||||||
REQUIP XL | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP XL | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP XL | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP XL | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP XL | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP XL | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA021433 - GLAXO GRP LTD | |||||||
FLOVENT HFA | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.22MG/INH | Prescription | |||
FLOVENT HFA | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.11MG/INH | Prescription | |||
FLOVENT HFA | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.044MG/INH | Prescription | |||
NDA021416 - GLAXOSMITHKLINE LLC | |||||||
RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 225MG | Discontinued | |||
RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 325MG | Discontinued | |||
RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 425MG | Discontinued | |||
NDA021254 - GLAXO GRP LTD | |||||||
ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | AEROSOL, METERED;INHALATION | 0.045MG/INH;EQ 0.021MG BASE/INH | Prescription | |||
ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | AEROSOL, METERED;INHALATION | 0.115MG/INH;EQ 0.021MG BASE/INH | Prescription | |||
ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | AEROSOL, METERED;INHALATION | 0.23MG/INH;EQ 0.021MG BASE/INH | Prescription | |||
NDA021078 - GLAXOSMITHKLINE | |||||||
MALARONE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | TABLET;ORAL | 250MG;100MG | Prescription | |||
MALARONE PEDIATRIC | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | TABLET;ORAL | 62.5MG;25MG | Prescription | |||
NDA021077 - GLAXO GRP LTD | |||||||
ADVAIR DISKUS 100/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.1MG/INH;EQ 0.05MG BASE/INH | Prescription | |||
ADVAIR DISKUS 250/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.25MG/INH;EQ 0.05MG BASE/INH | Prescription | |||
ADVAIR DISKUS 500/50 | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | POWDER;INHALATION | 0.5MG/INH;EQ 0.05MG BASE/INH | Prescription | |||
NDA021039 - GLAXOSMITHKLINE | |||||||
AGENERASE | AMPRENAVIR | SOLUTION;ORAL | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA021036 - GLAXOSMITHKLINE | |||||||
RELENZA | ZANAMIVIR | POWDER;INHALATION | 5MG | Prescription | |||
NDA021019 - GLAXOSMITHKLINE | |||||||
COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 15MG BASE | Discontinued | |||
COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 10MG BASE | Discontinued | |||
NDA021007 - GLAXOSMITHKLINE | |||||||
AGENERASE | AMPRENAVIR | CAPSULE;ORAL | 50MG | Discontinued | |||
AGENERASE | AMPRENAVIR | CAPSULE;ORAL | 150MG | Discontinued | |||
NDA021004 - GLAXOSMITHKLINE | |||||||
EPIVIR-HBV | LAMIVUDINE | SOLUTION;ORAL | 5MG/ML | Discontinued | |||
NDA021003 - GLAXOSMITHKLINE | |||||||
EPIVIR-HBV | LAMIVUDINE | TABLET;ORAL | 100MG | Discontinued | |||
NDA020983 - GLAXOSMITHKLINE | |||||||
VENTOLIN HFA | ALBUTEROL SULFATE | AEROSOL, METERED;INHALATION | EQ 0.09MG BASE/INH | Prescription | |||
NDA020951 - GLAXOSMITHKLINE | |||||||
TAGAMET HB 200 | CIMETIDINE | SUSPENSION;ORAL | 200MG/20ML | Discontinued | |||
NDA020833 - GLAXO GRP LTD | |||||||
FLOVENT DISKUS 50 | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.05MG/INH | Prescription | |||
FLOVENT DISKUS 100 | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.1MG/INH | Prescription | |||
FLOVENT DISKUS 250 | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.25MG/INH | Prescription | |||
NDA020764 - GLAXOSMITHKLINE LLC | |||||||
LAMICTAL CD | LAMOTRIGINE | TABLET, FOR SUSPENSION;ORAL | 25MG | Prescription | |||
LAMICTAL CD | LAMOTRIGINE | TABLET, FOR SUSPENSION;ORAL | 100MG | Discontinued | |||
LAMICTAL CD | LAMOTRIGINE | TABLET, FOR SUSPENSION;ORAL | 2MG | Prescription | |||
LAMICTAL CD | LAMOTRIGINE | TABLET, FOR SUSPENSION;ORAL | 5MG | Prescription | |||
NDA020763 - GLAXOSMITHKLINE LLC | |||||||
AMERGE | NARATRIPTAN HYDROCHLORIDE | TABLET;ORAL | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
AMERGE | NARATRIPTAN HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020711 - GLAXOSMITHKLINE | |||||||
ZYBAN | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Discontinued | |||
ZYBAN | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020692 - GLAXOSMITHKLINE | |||||||
SEREVENT | SALMETEROL XINAFOATE | POWDER;INHALATION | EQ 0.05MG BASE/INH | Prescription | |||
NDA020658 - GLAXOSMITHKLINE LLC | |||||||
REQUIP | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
REQUIP | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020626 - GLAXOSMITHKLINE | |||||||
IMITREX | SUMATRIPTAN | SPRAY;NASAL | 20MG/SPRAY | Prescription | |||
IMITREX | SUMATRIPTAN | SPRAY;NASAL | 10MG/SPRAY | Discontinued | |||
IMITREX | SUMATRIPTAN | SPRAY;NASAL | 5MG/SPRAY | Prescription | |||
NDA020559 - GLAXOSMITHKLINE | |||||||
TRITEC | RANITIDINE BISMUTH CITRATE | TABLET;ORAL | 400MG | Discontinued | |||
NDA020550 - GLAXOSMITHKLINE | |||||||
VALTREX | VALACYCLOVIR HYDROCHLORIDE | Tablet; Oral | EQ 500MG BASE | Prescription | |||
VALTREX | VALACYCLOVIR HYDROCHLORIDE | TABLET; ORAL | EQ 1GM BASE | Prescription | |||
NDA020549 - GLAXOSMITHKLINE | |||||||
FLOVENT | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.088MG/INH | Discontinued | |||
FLOVENT | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.22MG/INH | Discontinued | |||
FLOVENT | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.044MG/INH | Discontinued | |||
NDA020548 - GLAXOSMITHKLINE | |||||||
FLOVENT | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.11MG/INH | Discontinued | |||
FLOVENT | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.044MG/INH | Discontinued | |||
FLOVENT | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.22MG/INH | Discontinued | |||
NDA020500 - GLAXOSMITHKLINE LLC | |||||||
MEPRON | ATOVAQUONE | SUSPENSION;ORAL | 750MG/5ML | Prescription | |||
NDA020487 - GLAXOSMITHKLINE | |||||||
VALTREX | VALACYCLOVIR HYDROCHLORIDE | TABLET;ORAL | EQ 500MG BASE | Prescription | |||
VALTREX | VALACYCLOVIR HYDROCHLORIDE | TABLET;ORAL | EQ 1GM BASE | Prescription | |||
NDA020444 - GLAXOSMITHKLINE LLC | |||||||
FLOLAN | EPOPROSTENOL SODIUM | INJECTABLE;INJECTION | EQ 0.5MG BASE/VIAL | Prescription | |||
FLOLAN | EPOPROSTENOL SODIUM | INJECTABLE;INJECTION | EQ 1.5MG BASE/VIAL | Prescription | |||
NDA020403 - GLAXOSMITHKLINE | |||||||
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER | ONDANSETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020358 - GLAXOSMITHKLINE | |||||||
WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 50MG | Discontinued | |||
WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 100MG | Prescription | |||
WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 150MG | Prescription | |||
WELLBUTRIN SR | BUPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 200MG | Prescription | |||
NDA020336 - GLAXOSMITHKLINE LLC | |||||||
DYNACIRC CR | ISRADIPINE | TABLET, EXTENDED RELEASE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
DYNACIRC CR | ISRADIPINE | TABLET, EXTENDED RELEASE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020259 - GLAXOSMITHKLINE LLC | |||||||
MEPRON | ATOVAQUONE | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020251 - GLAXO GRP LTD | |||||||
ZANTAC 150 | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 150MG BASE | Discontinued | |||
ZANTAC 150 | RANITIDINE HYDROCHLORIDE | GRANULE, EFFERVESCENT;ORAL | EQ 150MG BASE/PACKET | Discontinued | |||
ZANTAC 25 | RANITIDINE HYDROCHLORIDE | TABLET, EFFERVESCENT;ORAL | EQ 25MG BASE | Discontinued | |||
NDA020250 - GLAXOSMITHKLINE | |||||||
HALFAN | HALOFANTRINE HYDROCHLORIDE | TABLET;ORAL | 250MG | Discontinued | |||
NDA020241 - GLAXOSMITHKLINE LLC | |||||||
LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 200MG | Prescription | |||
LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 150MG | Prescription | |||
LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 100MG | Prescription | |||
LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 25MG | Prescription | |||
NDA020236 - GLAXOSMITHKLINE | |||||||
SEREVENT | SALMETEROL XINAFOATE | AEROSOL, METERED;INHALATION | EQ 0.021MG BASE/INH | Discontinued | |||
NDA020132 - GLAXOSMITHKLINE | |||||||
IMITREX | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 25MG BASE | Prescription | |||
IMITREX | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 100MG BASE | Prescription | |||
IMITREX | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 50MG BASE | Prescription | |||
NDA020095 - GLAXOSMITHKLINE | |||||||
ZANTAC 150 | RANITIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ZANTAC 300 | RANITIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA020080 - GLAXOSMITHKLINE | |||||||
IMITREX | SUMATRIPTAN SUCCINATE | INJECTABLE;SUBCUTANEOUS | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
IMITREX STATDOSE | SUMATRIPTAN SUCCINATE | INJECTABLE;SUBCUTANEOUS | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | Prescription | |||
IMITREX STATDOSE | SUMATRIPTAN SUCCINATE | INJECTABLE;SUBCUTANEOUS | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | Prescription | |||
NDA020044 - GLAXOSMITHKLINE | |||||||
EXOSURF NEONATAL | CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL | FOR SUSPENSION;INTRATRACHEAL | 12MG/VIAL;108MG/VIAL;8MG/VIAL | Discontinued | |||
NDA019773 - GLAXOSMITHKLINE | |||||||
VENTOLIN | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019675 - GLAXO GRP LTD | |||||||
ZANTAC | RANITIDINE HYDROCHLORIDE | SYRUP;ORAL | EQ 15MG BASE/ML | Discontinued | |||
NDA019621 - GLAXOSMITHKLINE | |||||||
VENTOLIN | ALBUTEROL SULFATE | SYRUP;ORAL | EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019583 - SMITHKLINE BEECHAM | |||||||
RELAFEN | NABUMETONE | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
RELAFEN | NABUMETONE | TABLET;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019546 - SMITHKLINE BEECHAM | |||||||
DYNACIRC | ISRADIPINE | CAPSULE;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
DYNACIRC | ISRADIPINE | CAPSULE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019508 - SMITHKLINE BEECHAM | |||||||
AXID | NIZATIDINE | CAPSULE;ORAL | 150MG | Discontinued | |||
AXID | NIZATIDINE | CAPSULE;ORAL | 300MG | Discontinued | |||
NDA019489 - GLAXOSMITHKLINE | |||||||
VENTOLIN ROTACAPS | ALBUTEROL SULFATE | CAPSULE;INHALATION | EQ 0.2MG BASE | Discontinued | |||
NDA019435 - GLAXOSMITHKLINE | |||||||
NIX | PERMETHRIN | LOTION;TOPICAL | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019434 - GLAXOSMITHKLINE | |||||||
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CIMETIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019389 - GLAXOSMITHKLINE | |||||||
BECONASE AQ | BECLOMETHASONE DIPROPIONATE MONOHYDRATE | SPRAY, METERED;NASAL | EQ 0.042MG DIPROP/SPRAY | Discontinued | |||
NDA019269 - GLAXOSMITHKLINE | |||||||
VENTOLIN | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019174 - GLAXOSMITHKLINE | |||||||
TRANDATE HCT | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;200MG | Discontinued | |||
TRANDATE HCT | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;300MG | Discontinued | |||
TRANDATE HCT | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;400MG | Discontinued | |||
TRANDATE HCT | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;100MG | Discontinued | |||
NDA019151 - GLAXOSMITHKLINE LLC | |||||||
RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA019112 - GLAXOSMITHKLINE | |||||||
VENTOLIN | ALBUTEROL SULFATE | TABLET;ORAL | EQ 2MG BASE | Discontinued | |||
VENTOLIN | ALBUTEROL SULFATE | TABLET;ORAL | EQ 4MG BASE | Discontinued | |||
NDA018996 - GLAXOSMITHKLINE | |||||||
ACTIFED | PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG;5MG | Discontinued | |||
NDA018703 - GLAXO GRP LTD | |||||||
ZANTAC 150 | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ZANTAC 300 | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018644 - GLAXOSMITHKLINE | |||||||
WELLBUTRIN | BUPROPION HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
WELLBUTRIN | BUPROPION HYDROCHLORIDE | TABLET;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
WELLBUTRIN | BUPROPION HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018603 - GLAXOSMITHKLINE | |||||||
ZOVIRAX | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ZOVIRAX | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
ZOVIRAX | ACYCLOVIR SODIUM | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018584 - GLAXOSMITHKLINE | |||||||
BECONASE | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;NASAL | 0.042MG/INH | Discontinued | |||
NDA018473 - GLAXOSMITHKLINE | |||||||
VENTOLIN | ALBUTEROL | AEROSOL, METERED;INHALATION | 0.09MG/INH | Discontinued | |||
NDA018342 - GLAXOSMITHKLINE | |||||||
WELLCOVORIN | LEUCOVORIN CALCIUM | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
WELLCOVORIN | LEUCOVORIN CALCIUM | TABLET;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA018153 - GLAXOSMITHKLINE | |||||||
BECLOVENT | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;INHALATION | 0.042MG/INH | Discontinued | |||
NDA018118 - GLAXOSMITHKLINE LLC | |||||||
LANOXICAPS | DIGOXIN | CAPSULE;ORAL | 0.1MG | Discontinued | |||
LANOXICAPS | DIGOXIN | CAPSULE;ORAL | 0.15MG | Discontinued | |||
LANOXICAPS | DIGOXIN | CAPSULE;ORAL | 0.05MG | Discontinued | |||
LANOXICAPS | DIGOXIN | CAPSULE;ORAL | 0.2MG | Discontinued | |||
NDA017941 - GLAXOSMITHKLINE | |||||||
SUDAFED 12 HOUR | PSEUDOEPHEDRINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA017939 - GLAXOSMITHKLINE | |||||||
TAGAMET | CIMETIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA017924 - GLAXOSMITHKLINE | |||||||
TAGAMET | CIMETIDINE HYDROCHLORIDE | SOLUTION;ORAL | EQ 300MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA017920 - GLAXOSMITHKLINE | |||||||
TAGAMET | CIMETIDINE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
TAGAMET | CIMETIDINE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
TAGAMET | CIMETIDINE | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
TAGAMET | CIMETIDINE | TABLET;ORAL | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA017369 - GLAXOSMITHKLINE | |||||||
TELDRIN | CHLORPHENIRAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 8MG | Discontinued | |||
TELDRIN | CHLORPHENIRAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 12MG | Discontinued | |||
NDA017352 - GLAXOSMITHKLINE | |||||||
FASTIN | PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA016042 - GLAXOSMITHKLINE LLC | |||||||
DYAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | CAPSULE;ORAL | 25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
DYAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | CAPSULE;ORAL | 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA016033 - GLAXOSMITHKLINE | |||||||
VONTROL | DIPHENIDOL HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | Discontinued | |||
NDA015868 - GLAXOSMITHKLINE | |||||||
STOXIL | IDOXURIDINE | OINTMENT;OPHTHALMIC | 0.5% | Discontinued | |||
NDA013934 - GLAXOSMITHKLINE | |||||||
STOXIL | IDOXURIDINE | SOLUTION/DROPS;OPHTHALMIC | 0.1% | Discontinued | |||
NDA012575 - GLAXOSMITHKLINE | |||||||
ACTIFED W/ CODEINE | CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA011945 - GLAXOSMITHKLINE | |||||||
HISPRIL | DIPHENYLPYRALINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 5MG | Discontinued | |||
NDA011552 - GLAXOSMITHKLINE | |||||||
STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
STELAZINE | TRIFLUOPERAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA011496 - GLAXOSMITHKLINE | |||||||
ACTIDIL | TRIPROLIDINE HYDROCHLORIDE | SYRUP;ORAL | 1.25MG/5ML | Discontinued | |||
NDA011276 - GLAXOSMITHKLINE | |||||||
COMPAZINE | PROCHLORPERAZINE EDISYLATE | CONCENTRATE;ORAL | EQ 10MG BASE/ML | Discontinued | |||
NDA011188 - GLAXOSMITHKLINE | |||||||
COMPAZINE | PROCHLORPERAZINE EDISYLATE | SYRUP;ORAL | EQ 5MG BASE/5ML | Discontinued | |||
NDA011127 - GLAXOSMITHKLINE | |||||||
COMPAZINE | PROCHLORPERAZINE | SUPPOSITORY;RECTAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
COMPAZINE | PROCHLORPERAZINE | SUPPOSITORY;RECTAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
COMPAZINE | PROCHLORPERAZINE | SUPPOSITORY;RECTAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA011120 - GLAXOSMITHKLINE | |||||||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 75MG | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | Discontinued | |||
NDA011110 - GLAXOSMITHKLINE | |||||||
ACTIDIL | TRIPROLIDINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | Discontinued | |||
NDA011000 - GLAXOSMITHKLINE | |||||||
COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 10MG BASE | Discontinued | |||
COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 15MG BASE | Discontinued | |||
COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 30MG BASE | Discontinued | |||
COMPAZINE | PROCHLORPERAZINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 75MG BASE | Discontinued | |||
NDA010744 - GLAXOSMITHKLINE | |||||||
DARBID | ISOPROPAMIDE IODIDE | TABLET;ORAL | EQ 5MG BASE | Discontinued | |||
NDA010742 - GLAXOSMITHKLINE | |||||||
COMPAZINE | PROCHLORPERAZINE EDISYLATE | INJECTABLE;INJECTION | EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA010571 - GLAXOSMITHKLINE | |||||||
COMPAZINE | PROCHLORPERAZINE MALEATE | TABLET;ORAL | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
COMPAZINE | PROCHLORPERAZINE MALEATE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
COMPAZINE | PROCHLORPERAZINE MALEATE | TABLET;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA009495 - GLAXOSMITHKLINE | |||||||
MAREZINE | CYCLIZINE LACTATE | INJECTABLE;INJECTION | 50MG/ML | Discontinued | |||
NDA009309 - GLAXOSMITHKLINE | |||||||
DIONOSIL AQUEOUS | PROPYLIODONE | SUSPENSION;INTRATRACHEAL | 50% | Discontinued | |||
DIONOSIL OILY | PROPYLIODONE | SUSPENSION;INTRATRACHEAL | 60% | Discontinued | |||
NDA009149 - GLAXOSMITHKLINE | |||||||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | SYRUP;ORAL | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE | SUPPOSITORY;RECTAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE | SUPPOSITORY;RECTAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
THORAZINE | CHLORPROMAZINE HYDROCHLORIDE | CONCENTRATE;ORAL | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | |||
NDA009102 - GLAXOSMITHKLINE | |||||||
ANTEPAR | PIPERAZINE CITRATE | SYRUP;ORAL | EQ 500MG BASE/5ML | Discontinued | |||
ANTEPAR | PIPERAZINE CITRATE | TABLET;ORAL | EQ 500MG BASE | Discontinued | |||
NDA006931 - GLAXOSMITHKLINE | |||||||
SYNCURINE | DECAMETHONIUM BROMIDE | INJECTABLE;INJECTION | 1MG/ML | Discontinued | |||
NDA006772 - GLAXOSMITHKLINE | |||||||
VASOXYL | METHOXAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML | Discontinued | |||
VASOXYL | METHOXAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | Discontinued |