GSK plc

GSK plc (GSK)

FDA Applications

Note: This list only includes applications that have been responded to by the FDA.

ApplicationProduct NameActive IngredientFormStrengthStatus
BLA761223 - GLAXOSMITHKLINE LLC
JEMPERLIDOSTARLIMAB-GXLYINJECTABLE;INJECTION500MG/10MLPrescription
BLA761174 - GLAXOSMITHKLINE
JEMPERLIDOSTARLIMAB-GXLYINJECTABLE;INJECTION500MG/10MLPrescription
BLA761122 - GLAXOSMITHKLINE
NUCALAMEPOLIZUMABINJECTABLE;SUBCUTANEOUS100MG/MLPrescription
BLA761043 - GLAXOSMITHKLINE LLC
BENLYSTABELIMUMABINJECTABLE;INJECTION200MG/MLPrescription
NDA216951 - GLAXOSMITHKLINE
JESDUVROQDAPRODUSTATTABLET;ORAL1MGDiscontinued
JESDUVROQDAPRODUSTATTABLET;ORAL2MGDiscontinued
JESDUVROQDAPRODUSTATTABLET;ORAL4MGDiscontinued
JESDUVROQDAPRODUSTATTABLET;ORAL6MGDiscontinued
JESDUVROQDAPRODUSTATTABLET;ORAL8MGDiscontinued
NDA216873 - GLAXOSMITHKLINE
OJJAARAMOMELOTINIB DIHYDROCHLORIDETABLET;ORALEQ 100MG BASEPrescription
OJJAARAMOMELOTINIB DIHYDROCHLORIDETABLET;ORALEQ 150MG BASEPrescription
OJJAARAMOMELOTINIB DIHYDROCHLORIDETABLET;ORALEQ 200MG BASEPrescription
NDA214876 - GLAXOSMITHKLINE
ZEJULANIRAPARIB TOSYLATETABLET;ORALEQ 200MG BASEPrescription
ZEJULANIRAPARIB TOSYLATETABLET;ORALEQ 300MG BASEPrescription
ZEJULANIRAPARIB TOSYLATETABLET;ORALEQ 100MG BASEPrescription
NDA210795 - GLAXOSMITHKLINE
KRINTAFELTAFENOQUINE SUCCINATETABLET;ORALEQ 150MG BASEPrescription
NDA209482 - GLAXOSMITHKLINE
TRELEGY ELLIPTAFLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPrescription
TRELEGY ELLIPTAFLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPrescription
NDA208447 - GLAXOSMITHKLINE
ZEJULANIRAPARIB TOSYLATECAPSULE;ORALEQ 100MG BASEDiscontinued
NDA205625 - GLAXOSMITHKLINE
ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.2MG/INHPrescription
ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.1MG/INHPrescription
ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.05MG/INHPrescription
NDA205382 - GLAXO GRP ENGLAND
INCRUSE ELLIPTAUMECLIDINIUM BROMIDEPOWDER;INHALATIONEQ 0.0625MG BASE/INHPrescription
NDA204275 - GLAXO GRP LTD
BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.2MG/INH;EQ 0.025MG BASE/INHPrescription
BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.05MG/INH;EQ 0.025MG BASE/INHPrescription
BREO ELLIPTAFLUTICASONE FUROATE; VILANTEROL TRIFENATATEPOWDER;INHALATION0.1MG/INH;EQ 0.025MG BASE/INHPrescription
NDA203975 - GLAXOSMITHKLINE
ANORO ELLIPTAUMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATEPOWDER;INHALATIONEQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INHPrescription
BLA125526 - GLAXOSMITHKLINE LLC
NUCALAMEPOLIZUMABINJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER100MGPrescription
BLA125431 - GLAXOSMITHKLINE LLC
TANZEUMALBIGLUTIDEINJECTABLE;INJECTION30MGDiscontinued
ANDA089834 - GLAXOSMITHKLINE
WELLCOVORINLEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIALDiscontinued
ANDA089833 - GLAXOSMITHKLINE
WELLCOVORINLEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 25MG BASE/VIALDiscontinued
ANDA089465 - GLAXOSMITHKLINE
WELLCOVORINLEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 50MG BASE/VIALDiscontinued
ANDA087439 - GLAXOSMITHKLINE
WELLCOVORINLEUCOVORIN CALCIUMSOLUTION;INTRAMUSCULAR, INTRAVENOUSEQ 5MG BASE/ML (EQ 5MG BASE/ML)Discontinued
WELLCOVORINLEUCOVORIN CALCIUMSOLUTION;INTRAMUSCULAR, INTRAVENOUSEQ 25MG BASE/5ML (EQ 5MG BASE/ML)Discontinued
ANDA084935 - GLAXOSMITHKLINE
DEXEDRINEDEXTROAMPHETAMINE SULFATETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANDA084060 - GLAXOSMITHKLINE
PHYTONADIONEPHYTONADIONEINJECTABLE;INJECTION1MG/0.5MLDiscontinued
PHYTONADIONEPHYTONADIONEINJECTABLE;INJECTION10MG/MLDiscontinued
ANDA083951 - GLAXOSMITHKLINE
EMPRACET W/ CODEINE PHOSPHATE #3ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGDiscontinued
EMPRACET W/ CODEINE PHOSPHATE #4ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;60MGDiscontinued
ANDA083902 - GLAXOSMITHKLINE
DEXEDRINEDEXTROAMPHETAMINE SULFATEELIXIR;ORAL5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANDA077658 - GLAXOSMITHKLINE CONS
THRIVENICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 2MG BASEDiscontinued
ANDA077656 - GLAXOSMITHKLINE CONS
THRIVENICOTINE POLACRILEXGUM, CHEWING;BUCCALEQ 4MG BASEDiscontinued
ANDA075822 - GLAXOSMITHKLINE
LORATADINELORATADINETABLET, ORALLY DISINTEGRATING;ORAL10MGDiscontinued
ANDA064033 - GLAXOSMITHKLINE
CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
ANDA064008 - GLAXOSMITHKLINE
PENTACEFCEFTAZIDIMEINJECTABLE;INJECTION10GM/VIALDiscontinued
PENTACEFCEFTAZIDIMEINJECTABLE;INJECTION6GM/VIALDiscontinued
ANDA064006 - GLAXOSMITHKLINE
PENTACEFCEFTAZIDIMEINJECTABLE;INJECTION2GM/VIALDiscontinued
PENTACEFCEFTAZIDIMEINJECTABLE;INJECTION1GM/VIALDiscontinued
ANDA063322 - GLAXOSMITHKLINE
PENTACEFCEFTAZIDIMEINJECTABLE;INJECTION2GM/VIALDiscontinued
PENTACEFCEFTAZIDIMEINJECTABLE;INJECTION1GM/VIALDiscontinued
ANDA063295 - GLAXOSMITHKLINE
MONOCIDCEFONICID SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
ANDA062755 - GLAXOSMITHKLINE
NALLPENNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
NALLPENNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
ANDA062736 - GLAXOSMITHKLINE
BACTOCILLOXACILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BACTOCILLOXACILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANDA062727 - GLAXOSMITHKLINE
TOTACILLIN-NAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
TOTACILLIN-NAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
ANDA062691 - GLAXOSMITHKLINE
TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALDiscontinued
ANDA062690 - GLAXOSMITHKLINE
TICARTICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 3GM BASE/VIALDiscontinued
ANDA062435 - GLAXOSMITHKLINE
SEFFINCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALDiscontinued
SEFFINCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
SEFFINCEPHALOTHIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
ANDA062321 - GLAXOSMITHKLINE
BACTOCILLOXACILLIN SODIUMFOR SOLUTION;ORALEQ 250MG BASE/5MLDiscontinued
ANDA062273 - GLAXOSMITHKLINE
BEEPEN-VKPENICILLIN V POTASSIUMTABLET;ORALEQ 500MG BASEDiscontinued
BEEPEN-VKPENICILLIN V POTASSIUMTABLET;ORALEQ 250MG BASEDiscontinued
ANDA062270 - GLAXOSMITHKLINE
BEEPEN-VKPENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 125MG BASE/5MLDiscontinued
BEEPEN-VKPENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 250MG BASE/5MLDiscontinued
ANDA062241 - GLAXOSMITHKLINE
BACTOCILLOXACILLIN SODIUMCAPSULE;ORALEQ 250MG BASEDiscontinued
BACTOCILLOXACILLIN SODIUMCAPSULE;ORALEQ 500MG BASEDiscontinued
ANDA062238 - GLAXOSMITHKLINE
DYCILLDICLOXACILLIN SODIUMCAPSULE;ORALEQ 500MG BASEDiscontinued
DYCILLDICLOXACILLIN SODIUMCAPSULE;ORALEQ 250MG BASEDiscontinued
ANDA062233 - GLAXOSMITHKLINE
CLOXAPENCLOXACILLIN SODIUMCAPSULE;ORALEQ 250MG BASEDiscontinued
CLOXAPENCLOXACILLIN SODIUMCAPSULE;ORALEQ 500MG BASEDiscontinued
ANDA062223 - GLAXOSMITHKLINE
TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATEFOR SUSPENSION;ORALEQ 125MG BASE/5MLDiscontinued
TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATEFOR SUSPENSION;ORALEQ 250MG BASE/5MLDiscontinued
ANDA062212 - GLAXOSMITHKLINE
TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALEQ 250MG BASEDiscontinued
TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALEQ 500MG BASEDiscontinued
ANDA062036 - GLAXOSMITHKLINE
AEROSPORINPOLYMYXIN B SULFATEINJECTABLE;INJECTIONEQ 500,000 UNITS BASE/VIALDiscontinued
ANDA061999 - GLAXOSMITHKLINE
NALLPENNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
NALLPENNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALDiscontinued
NALLPENNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALDiscontinued
NALLPENNAFCILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
ANDA061866 - GLAXOSMITHKLINE
ANSPORCEPHRADINEFOR SUSPENSION;ORAL250MG/5MLDiscontinued
ANSPORCEPHRADINEFOR SUSPENSION;ORAL125MG/5MLDiscontinued
ANDA061859 - GLAXOSMITHKLINE
ANSPORCEPHRADINECAPSULE;ORAL500MGDiscontinued
ANSPORCEPHRADINECAPSULE;ORAL250MGDiscontinued
ANDA061806 - GLAXOSMITHKLINE
CLOXAPENCLOXACILLIN SODIUMCAPSULE;ORALEQ 250MG BASEDiscontinued
CLOXAPENCLOXACILLIN SODIUMCAPSULE;ORALEQ 500MG BASEDiscontinued
ANDA061336 - GLAXOSMITHKLINE
BACTOCILLOXACILLIN SODIUMCAPSULE;ORALEQ 500MG BASEDiscontinued
BACTOCILLOXACILLIN SODIUMCAPSULE;ORALEQ 250MG BASEDiscontinued
ANDA061334 - GLAXOSMITHKLINE
BACTOCILLOXACILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BACTOCILLOXACILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BACTOCILLOXACILLIN SODIUMINJECTABLE;INJECTIONEQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BACTOCILLOXACILLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BACTOCILLOXACILLIN SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANDA060677 - GLAXOSMITHKLINE
TOTACILLIN-NAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 125MG BASE/VIALDiscontinued
TOTACILLIN-NAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 250MG BASE/VIALDiscontinued
TOTACILLIN-NAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALDiscontinued
TOTACILLIN-NAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
TOTACILLIN-NAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALDiscontinued
TOTACILLIN-NAMPICILLIN SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
ANDA060666 - GLAXOSMITHKLINE
TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATEFOR SUSPENSION;ORALEQ 125MG BASE/5MLDiscontinued
TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATEFOR SUSPENSION;ORALEQ 250MG BASE/5MLDiscontinued
ANDA060254 - GLAXOSMITHKLINE
DYCILLDICLOXACILLIN SODIUMCAPSULE;ORALEQ 500MG BASEDiscontinued
DYCILLDICLOXACILLIN SODIUMCAPSULE;ORALEQ 250MG BASEDiscontinued
ANDA060060 - GLAXOSMITHKLINE
TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALEQ 250MG BASEDiscontinued
TOTACILLINAMPICILLIN/AMPICILLIN TRIHYDRATECAPSULE;ORALEQ 500MG BASEDiscontinued
NDA050746 - GLAXOSMITHKLINE
BACTROBANMUPIROCIN CALCIUMCREAM;TOPICALEQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050703 - GLAXOSMITHKLINE
BACTROBANMUPIROCIN CALCIUMOINTMENT;NASALEQ 2% BASEDiscontinued
NDA050672 - GLAXOSMITHKLINE
CEFTINCEFUROXIME AXETILFOR SUSPENSION;ORALEQ 250MG BASE/5MLDiscontinued
CEFTINCEFUROXIME AXETILFOR SUSPENSION;ORALEQ 125MG BASE/5MLDiscontinued
NDA050658 - GLAXOSMITHKLINE
TIMENTIN IN PLASTIC CONTAINERCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 100MG BASE/100ML;EQ 3GM BASE/100MLDiscontinued
NDA050646 - GLAXOSMITHKLINE
CEPTAZCEFTAZIDIMEINJECTABLE;INJECTION500MG/VIALDiscontinued
CEPTAZCEFTAZIDIMEINJECTABLE;INJECTION1GM/VIALDiscontinued
CEPTAZCEFTAZIDIMEINJECTABLE;INJECTION2GM/VIALDiscontinued
CEPTAZCEFTAZIDIMEINJECTABLE;INJECTION10GM/VIALDiscontinued
NDA050605 - GLAXOSMITHKLINE
CEFTINCEFUROXIME AXETILTABLET;ORALEQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CEFTINCEFUROXIME AXETILTABLET;ORALEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CEFTINCEFUROXIME AXETILTABLET;ORALEQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050591 - GLAXOSMITHKLINE
BACTROBANMUPIROCINOINTMENT;TOPICAL2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050590 - GLAXOSMITHKLINE
TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIAL;EQ 3GM BASE/VIALDiscontinued
TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 30GM BASE/VIALDiscontinued
TIMENTINCLAVULANATE POTASSIUM; TICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 200MG BASE/VIAL;EQ 3GM BASE/VIALDiscontinued
NDA050579 - GLAXOSMITHKLINE
MONOCIDCEFONICID SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALDiscontinued
MONOCIDCEFONICID SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
MONOCIDCEFONICID SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
MONOCIDCEFONICID SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALDiscontinued
NDA050497 - GLAXOSMITHKLINE
TICARTICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 30GM BASE/VIALDiscontinued
TICARTICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 20GM BASE/VIALDiscontinued
TICARTICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 3GM BASE/VIALDiscontinued
TICARTICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 6GM BASE/VIALDiscontinued
TICARTICARCILLIN DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
NDA050461 - GLAXOSMITHKLINE
ANCEFCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANCEFCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANCEFCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANCEFCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANCEFCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050460 - GLAXOSMITHKLINE
AMOXILAMOXICILLINFOR SUSPENSION;ORAL125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
AMOXILAMOXICILLINFOR SUSPENSION;ORAL250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
AMOXILAMOXICILLINFOR SUSPENSION;ORAL50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
LAROTIDAMOXICILLINFOR SUSPENSION;ORAL50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050459 - GLAXOSMITHKLINE
AMOXILAMOXICILLINCAPSULE;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
AMOXILAMOXICILLINCAPSULE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050298 - GLAXOSMITHKLINE
PYOPENCARBENICILLIN DISODIUMINJECTABLE;INJECTIONEQ 5GM BASE/VIALDiscontinued
PYOPENCARBENICILLIN DISODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALDiscontinued
PYOPENCARBENICILLIN DISODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALDiscontinued
PYOPENCARBENICILLIN DISODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIALDiscontinued
PYOPENCARBENICILLIN DISODIUMINJECTABLE;INJECTIONEQ 20GM BASE/VIALDiscontinued
NDA050176 - GLAXOSMITHKLINE
NEOSPORINNEOMYCIN SULFATE; POLYMYXIN B SULFATECREAM;TOPICALEQ 3.5MG BASE/GM;10,000 UNITS/GMDiscontinued
NDA050167 - GLAXOSMITHKLINE
POLYSPORINBACITRACIN ZINC; POLYMYXIN B SULFATEAEROSOL;TOPICAL10,000 UNITS/GM;2,000,000 UNITS/GMDiscontinued
NDA022509 - SMITHKLINE BEECHAM
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL25MGPrescription
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL50MGPrescription
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL100MGPrescription
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE; ORAL200MGPrescription
NDA022345 - GLAXOSMITHKLINE
POTIGAEZOGABINETABLET;ORAL200MGDiscontinued
POTIGAEZOGABINETABLET;ORAL300MGDiscontinued
POTIGAEZOGABINETABLET;ORAL50MGDiscontinued
POTIGAEZOGABINETABLET;ORAL400MGDiscontinued
NDA022251 - GLAXOSMITHKLINE LLC
LAMICTAL ODTLAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL50MGPrescription
LAMICTAL ODTLAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL100MGPrescription
LAMICTAL ODTLAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL200MGPrescription
LAMICTAL ODTLAMOTRIGINETABLET, ORALLY DISINTEGRATING;ORAL25MGPrescription
NDA022115 - GLAXOSMITHKLINE LLC
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL200MGPrescription
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL300MGPrescription
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL250MGPrescription
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL100MGPrescription
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL50MGPrescription
LAMICTAL XRLAMOTRIGINETABLET, EXTENDED RELEASE;ORAL25MGPrescription
NDA022008 - GLAXOSMITHKLINE LLC
REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIP XLROPINIROLE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA021433 - GLAXO GRP LTD
FLOVENT HFAFLUTICASONE PROPIONATEAEROSOL, METERED;INHALATION0.22MG/INHPrescription
FLOVENT HFAFLUTICASONE PROPIONATEAEROSOL, METERED;INHALATION0.11MG/INHPrescription
FLOVENT HFAFLUTICASONE PROPIONATEAEROSOL, METERED;INHALATION0.044MG/INHPrescription
NDA021416 - GLAXOSMITHKLINE LLC
RYTHMOL SRPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL225MGDiscontinued
RYTHMOL SRPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL325MGDiscontinued
RYTHMOL SRPROPAFENONE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL425MGDiscontinued
NDA021254 - GLAXO GRP LTD
ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.045MG/INH;EQ 0.021MG BASE/INHPrescription
ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.115MG/INH;EQ 0.021MG BASE/INHPrescription
ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.23MG/INH;EQ 0.021MG BASE/INHPrescription
NDA021078 - GLAXOSMITHKLINE
MALARONEATOVAQUONE; PROGUANIL HYDROCHLORIDETABLET;ORAL250MG;100MGPrescription
MALARONE PEDIATRICATOVAQUONE; PROGUANIL HYDROCHLORIDETABLET;ORAL62.5MG;25MGPrescription
NDA021077 - GLAXO GRP LTD
ADVAIR DISKUS 100/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.1MG/INH;EQ 0.05MG BASE/INHPrescription
ADVAIR DISKUS 250/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.25MG/INH;EQ 0.05MG BASE/INHPrescription
ADVAIR DISKUS 500/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.5MG/INH;EQ 0.05MG BASE/INHPrescription
NDA021039 - GLAXOSMITHKLINE
AGENERASEAMPRENAVIRSOLUTION;ORAL15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA021036 - GLAXOSMITHKLINE
RELENZAZANAMIVIRPOWDER;INHALATION5MGPrescription
NDA021019 - GLAXOSMITHKLINE
COMPAZINEPROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALEQ 15MG BASEDiscontinued
COMPAZINEPROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALEQ 10MG BASEDiscontinued
NDA021007 - GLAXOSMITHKLINE
AGENERASEAMPRENAVIRCAPSULE;ORAL50MGDiscontinued
AGENERASEAMPRENAVIRCAPSULE;ORAL150MGDiscontinued
NDA021004 - GLAXOSMITHKLINE
EPIVIR-HBVLAMIVUDINESOLUTION;ORAL5MG/MLDiscontinued
NDA021003 - GLAXOSMITHKLINE
EPIVIR-HBVLAMIVUDINETABLET;ORAL100MGDiscontinued
NDA020983 - GLAXOSMITHKLINE
VENTOLIN HFAALBUTEROL SULFATEAEROSOL, METERED;INHALATIONEQ 0.09MG BASE/INHPrescription
NDA020951 - GLAXOSMITHKLINE
TAGAMET HB 200CIMETIDINESUSPENSION;ORAL200MG/20MLDiscontinued
NDA020833 - GLAXO GRP LTD
FLOVENT DISKUS 50FLUTICASONE PROPIONATEPOWDER;INHALATION0.05MG/INHPrescription
FLOVENT DISKUS 100FLUTICASONE PROPIONATEPOWDER;INHALATION0.1MG/INHPrescription
FLOVENT DISKUS 250FLUTICASONE PROPIONATEPOWDER;INHALATION0.25MG/INHPrescription
NDA020764 - GLAXOSMITHKLINE LLC
LAMICTAL CDLAMOTRIGINETABLET, FOR SUSPENSION;ORAL25MGPrescription
LAMICTAL CDLAMOTRIGINETABLET, FOR SUSPENSION;ORAL100MGDiscontinued
LAMICTAL CDLAMOTRIGINETABLET, FOR SUSPENSION;ORAL2MGPrescription
LAMICTAL CDLAMOTRIGINETABLET, FOR SUSPENSION;ORAL5MGPrescription
NDA020763 - GLAXOSMITHKLINE LLC
AMERGENARATRIPTAN HYDROCHLORIDETABLET;ORALEQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
AMERGENARATRIPTAN HYDROCHLORIDETABLET;ORALEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020711 - GLAXOSMITHKLINE
ZYBANBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGDiscontinued
ZYBANBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020692 - GLAXOSMITHKLINE
SEREVENTSALMETEROL XINAFOATEPOWDER;INHALATIONEQ 0.05MG BASE/INHPrescription
NDA020658 - GLAXOSMITHKLINE LLC
REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
REQUIPROPINIROLE HYDROCHLORIDETABLET;ORALEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020626 - GLAXOSMITHKLINE
IMITREXSUMATRIPTANSPRAY;NASAL20MG/SPRAYPrescription
IMITREXSUMATRIPTANSPRAY;NASAL10MG/SPRAYDiscontinued
IMITREXSUMATRIPTANSPRAY;NASAL5MG/SPRAYPrescription
NDA020559 - GLAXOSMITHKLINE
TRITECRANITIDINE BISMUTH CITRATETABLET;ORAL400MGDiscontinued
NDA020550 - GLAXOSMITHKLINE
VALTREXVALACYCLOVIR HYDROCHLORIDETablet; OralEQ 500MG BASEPrescription
VALTREXVALACYCLOVIR HYDROCHLORIDETABLET; ORALEQ 1GM BASEPrescription
NDA020549 - GLAXOSMITHKLINE
FLOVENTFLUTICASONE PROPIONATEPOWDER;INHALATION0.088MG/INHDiscontinued
FLOVENTFLUTICASONE PROPIONATEPOWDER;INHALATION0.22MG/INHDiscontinued
FLOVENTFLUTICASONE PROPIONATEPOWDER;INHALATION0.044MG/INHDiscontinued
NDA020548 - GLAXOSMITHKLINE
FLOVENTFLUTICASONE PROPIONATEAEROSOL, METERED;INHALATION0.11MG/INHDiscontinued
FLOVENTFLUTICASONE PROPIONATEAEROSOL, METERED;INHALATION0.044MG/INHDiscontinued
FLOVENTFLUTICASONE PROPIONATEAEROSOL, METERED;INHALATION0.22MG/INHDiscontinued
NDA020500 - GLAXOSMITHKLINE LLC
MEPRONATOVAQUONESUSPENSION;ORAL750MG/5MLPrescription
NDA020487 - GLAXOSMITHKLINE
VALTREXVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 500MG BASEPrescription
VALTREXVALACYCLOVIR HYDROCHLORIDETABLET;ORALEQ 1GM BASEPrescription
NDA020444 - GLAXOSMITHKLINE LLC
FLOLANEPOPROSTENOL SODIUMINJECTABLE;INJECTIONEQ 0.5MG BASE/VIALPrescription
FLOLANEPOPROSTENOL SODIUMINJECTABLE;INJECTIONEQ 1.5MG BASE/VIALPrescription
NDA020403 - GLAXOSMITHKLINE
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.64MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020358 - GLAXOSMITHKLINE
WELLBUTRIN SRBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL50MGDiscontinued
WELLBUTRIN SRBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGPrescription
WELLBUTRIN SRBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGPrescription
WELLBUTRIN SRBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL200MGPrescription
NDA020336 - GLAXOSMITHKLINE LLC
DYNACIRC CRISRADIPINETABLET, EXTENDED RELEASE;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
DYNACIRC CRISRADIPINETABLET, EXTENDED RELEASE;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020259 - GLAXOSMITHKLINE LLC
MEPRONATOVAQUONETABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020251 - GLAXO GRP LTD
ZANTAC 150RANITIDINE HYDROCHLORIDETABLET, EFFERVESCENT;ORALEQ 150MG BASEDiscontinued
ZANTAC 150RANITIDINE HYDROCHLORIDEGRANULE, EFFERVESCENT;ORALEQ 150MG BASE/PACKETDiscontinued
ZANTAC 25RANITIDINE HYDROCHLORIDETABLET, EFFERVESCENT;ORALEQ 25MG BASEDiscontinued
NDA020250 - GLAXOSMITHKLINE
HALFANHALOFANTRINE HYDROCHLORIDETABLET;ORAL250MGDiscontinued
NDA020241 - GLAXOSMITHKLINE LLC
LAMICTALLAMOTRIGINETABLET;ORAL200MGPrescription
LAMICTALLAMOTRIGINETABLET;ORAL150MGPrescription
LAMICTALLAMOTRIGINETABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
LAMICTALLAMOTRIGINETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
LAMICTALLAMOTRIGINETABLET;ORAL100MGPrescription
LAMICTALLAMOTRIGINETABLET;ORAL25MGPrescription
NDA020236 - GLAXOSMITHKLINE
SEREVENTSALMETEROL XINAFOATEAEROSOL, METERED;INHALATIONEQ 0.021MG BASE/INHDiscontinued
NDA020132 - GLAXOSMITHKLINE
IMITREXSUMATRIPTAN SUCCINATETABLET;ORALEQ 25MG BASEPrescription
IMITREXSUMATRIPTAN SUCCINATETABLET;ORALEQ 100MG BASEPrescription
IMITREXSUMATRIPTAN SUCCINATETABLET;ORALEQ 50MG BASEPrescription
NDA020095 - GLAXOSMITHKLINE
ZANTAC 150RANITIDINE HYDROCHLORIDECAPSULE;ORALEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ZANTAC 300RANITIDINE HYDROCHLORIDECAPSULE;ORALEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020080 - GLAXOSMITHKLINE
IMITREXSUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 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 STATDOSESUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)Prescription
IMITREX STATDOSESUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)Prescription
NDA020044 - GLAXOSMITHKLINE
EXOSURF NEONATALCETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOLFOR SUSPENSION;INTRATRACHEAL12MG/VIAL;108MG/VIAL;8MG/VIALDiscontinued
NDA019773 - GLAXOSMITHKLINE
VENTOLINALBUTEROL SULFATESOLUTION;INHALATIONEQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019675 - GLAXO GRP LTD
ZANTACRANITIDINE HYDROCHLORIDESYRUP;ORALEQ 15MG BASE/MLDiscontinued
NDA019621 - GLAXOSMITHKLINE
VENTOLINALBUTEROL SULFATESYRUP;ORALEQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019583 - SMITHKLINE BEECHAM
RELAFENNABUMETONETABLET;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
RELAFENNABUMETONETABLET;ORAL750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019546 - SMITHKLINE BEECHAM
DYNACIRCISRADIPINECAPSULE;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
DYNACIRCISRADIPINECAPSULE;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019508 - SMITHKLINE BEECHAM
AXIDNIZATIDINECAPSULE;ORAL150MGDiscontinued
AXIDNIZATIDINECAPSULE;ORAL300MGDiscontinued
NDA019489 - GLAXOSMITHKLINE
VENTOLIN ROTACAPSALBUTEROL SULFATECAPSULE;INHALATIONEQ 0.2MG BASEDiscontinued
NDA019435 - GLAXOSMITHKLINE
NIXPERMETHRINLOTION;TOPICAL1% **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 CONTAINERCIMETIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 6MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019389 - GLAXOSMITHKLINE
BECONASE AQBECLOMETHASONE DIPROPIONATE MONOHYDRATESPRAY, METERED;NASALEQ 0.042MG DIPROP/SPRAYDiscontinued
NDA019269 - GLAXOSMITHKLINE
VENTOLINALBUTEROL SULFATESOLUTION;INHALATIONEQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019174 - GLAXOSMITHKLINE
TRANDATE HCTHYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDETABLET;ORAL25MG;200MGDiscontinued
TRANDATE HCTHYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDETABLET;ORAL25MG;300MGDiscontinued
TRANDATE HCTHYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDETABLET;ORAL25MG;400MGDiscontinued
TRANDATE HCTHYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDETABLET;ORAL25MG;100MGDiscontinued
NDA019151 - GLAXOSMITHKLINE LLC
RYTHMOLPROPAFENONE HYDROCHLORIDETABLET;ORAL150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
RYTHMOLPROPAFENONE HYDROCHLORIDETABLET;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
RYTHMOLPROPAFENONE HYDROCHLORIDETABLET;ORAL225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019112 - GLAXOSMITHKLINE
VENTOLINALBUTEROL SULFATETABLET;ORALEQ 2MG BASEDiscontinued
VENTOLINALBUTEROL SULFATETABLET;ORALEQ 4MG BASEDiscontinued
NDA018996 - GLAXOSMITHKLINE
ACTIFEDPSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MG;5MGDiscontinued
NDA018703 - GLAXO GRP LTD
ZANTAC 150RANITIDINE HYDROCHLORIDETABLET;ORALEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ZANTAC 300RANITIDINE HYDROCHLORIDETABLET;ORALEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018644 - GLAXOSMITHKLINE
WELLBUTRINBUPROPION HYDROCHLORIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
WELLBUTRINBUPROPION HYDROCHLORIDETABLET;ORAL75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
WELLBUTRINBUPROPION HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018603 - GLAXOSMITHKLINE
ZOVIRAXACYCLOVIR SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ZOVIRAXACYCLOVIR SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ZOVIRAXACYCLOVIR SODIUMINJECTABLE;INJECTIONEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018584 - GLAXOSMITHKLINE
BECONASEBECLOMETHASONE DIPROPIONATEAEROSOL, METERED;NASAL0.042MG/INHDiscontinued
NDA018473 - GLAXOSMITHKLINE
VENTOLINALBUTEROLAEROSOL, METERED;INHALATION0.09MG/INHDiscontinued
NDA018342 - GLAXOSMITHKLINE
WELLCOVORINLEUCOVORIN CALCIUMTABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
WELLCOVORINLEUCOVORIN CALCIUMTABLET;ORALEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018153 - GLAXOSMITHKLINE
BECLOVENTBECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATION0.042MG/INHDiscontinued
NDA018118 - GLAXOSMITHKLINE LLC
LANOXICAPSDIGOXINCAPSULE;ORAL0.1MGDiscontinued
LANOXICAPSDIGOXINCAPSULE;ORAL0.15MGDiscontinued
LANOXICAPSDIGOXINCAPSULE;ORAL0.05MGDiscontinued
LANOXICAPSDIGOXINCAPSULE;ORAL0.2MGDiscontinued
NDA017941 - GLAXOSMITHKLINE
SUDAFED 12 HOURPSEUDOEPHEDRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA017939 - GLAXOSMITHKLINE
TAGAMETCIMETIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 300MG BASE/2ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA017924 - GLAXOSMITHKLINE
TAGAMETCIMETIDINE HYDROCHLORIDESOLUTION;ORALEQ 300MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA017920 - GLAXOSMITHKLINE
TAGAMETCIMETIDINETABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
TAGAMETCIMETIDINETABLET;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
TAGAMETCIMETIDINETABLET;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
TAGAMETCIMETIDINETABLET;ORAL800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA017369 - GLAXOSMITHKLINE
TELDRINCHLORPHENIRAMINE MALEATECAPSULE, EXTENDED RELEASE;ORAL8MGDiscontinued
TELDRINCHLORPHENIRAMINE MALEATECAPSULE, EXTENDED RELEASE;ORAL12MGDiscontinued
NDA017352 - GLAXOSMITHKLINE
FASTINPHENTERMINE HYDROCHLORIDECAPSULE;ORAL30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA016042 - GLAXOSMITHKLINE LLC
DYAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENECAPSULE;ORAL25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
DYAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENECAPSULE;ORAL25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA016033 - GLAXOSMITHKLINE
VONTROLDIPHENIDOL HYDROCHLORIDETABLET;ORALEQ 25MG BASEDiscontinued
NDA015868 - GLAXOSMITHKLINE
STOXILIDOXURIDINEOINTMENT;OPHTHALMIC0.5%Discontinued
NDA013934 - GLAXOSMITHKLINE
STOXILIDOXURIDINESOLUTION/DROPS;OPHTHALMIC0.1%Discontinued
NDA012575 - GLAXOSMITHKLINE
ACTIFED W/ CODEINECODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDESYRUP;ORAL10MG/5ML;30MG/5ML;1.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA011945 - GLAXOSMITHKLINE
HISPRILDIPHENYLPYRALINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL5MGDiscontinued
NDA011552 - GLAXOSMITHKLINE
STELAZINETRIFLUOPERAZINE HYDROCHLORIDETABLET;ORALEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
STELAZINETRIFLUOPERAZINE HYDROCHLORIDETABLET;ORALEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
STELAZINETRIFLUOPERAZINE HYDROCHLORIDETABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
STELAZINETRIFLUOPERAZINE HYDROCHLORIDETABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
STELAZINETRIFLUOPERAZINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
STELAZINETRIFLUOPERAZINE HYDROCHLORIDECONCENTRATE;ORALEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA011496 - GLAXOSMITHKLINE
ACTIDILTRIPROLIDINE HYDROCHLORIDESYRUP;ORAL1.25MG/5MLDiscontinued
NDA011276 - GLAXOSMITHKLINE
COMPAZINEPROCHLORPERAZINE EDISYLATECONCENTRATE;ORALEQ 10MG BASE/MLDiscontinued
NDA011188 - GLAXOSMITHKLINE
COMPAZINEPROCHLORPERAZINE EDISYLATESYRUP;ORALEQ 5MG BASE/5MLDiscontinued
NDA011127 - GLAXOSMITHKLINE
COMPAZINEPROCHLORPERAZINESUPPOSITORY;RECTAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
COMPAZINEPROCHLORPERAZINESUPPOSITORY;RECTAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
COMPAZINEPROCHLORPERAZINESUPPOSITORY;RECTAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA011120 - GLAXOSMITHKLINE
THORAZINECHLORPROMAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGDiscontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL75MGDiscontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL150MGDiscontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL200MGDiscontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGDiscontinued
NDA011110 - GLAXOSMITHKLINE
ACTIDILTRIPROLIDINE HYDROCHLORIDETABLET;ORAL2.5MGDiscontinued
NDA011000 - GLAXOSMITHKLINE
COMPAZINEPROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALEQ 10MG BASEDiscontinued
COMPAZINEPROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALEQ 15MG BASEDiscontinued
COMPAZINEPROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALEQ 30MG BASEDiscontinued
COMPAZINEPROCHLORPERAZINE MALEATECAPSULE, EXTENDED RELEASE;ORALEQ 75MG BASEDiscontinued
NDA010744 - GLAXOSMITHKLINE
DARBIDISOPROPAMIDE IODIDETABLET;ORALEQ 5MG BASEDiscontinued
NDA010742 - GLAXOSMITHKLINE
COMPAZINEPROCHLORPERAZINE EDISYLATEINJECTABLE;INJECTIONEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA010571 - GLAXOSMITHKLINE
COMPAZINEPROCHLORPERAZINE MALEATETABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
COMPAZINEPROCHLORPERAZINE MALEATETABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
COMPAZINEPROCHLORPERAZINE MALEATETABLET;ORALEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA009495 - GLAXOSMITHKLINE
MAREZINECYCLIZINE LACTATEINJECTABLE;INJECTION50MG/MLDiscontinued
NDA009309 - GLAXOSMITHKLINE
DIONOSIL AQUEOUSPROPYLIODONESUSPENSION;INTRATRACHEAL50%Discontinued
DIONOSIL OILYPROPYLIODONESUSPENSION;INTRATRACHEAL60%Discontinued
NDA009149 - GLAXOSMITHKLINE
THORAZINECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDESYRUP;ORAL10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINESUPPOSITORY;RECTAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDECONCENTRATE;ORAL30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINESUPPOSITORY;RECTAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
THORAZINECHLORPROMAZINE HYDROCHLORIDECONCENTRATE;ORAL100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA009102 - GLAXOSMITHKLINE
ANTEPARPIPERAZINE CITRATESYRUP;ORALEQ 500MG BASE/5MLDiscontinued
ANTEPARPIPERAZINE CITRATETABLET;ORALEQ 500MG BASEDiscontinued
NDA006931 - GLAXOSMITHKLINE
SYNCURINEDECAMETHONIUM BROMIDEINJECTABLE;INJECTION1MG/MLDiscontinued
NDA006772 - GLAXOSMITHKLINE
VASOXYLMETHOXAMINE HYDROCHLORIDEINJECTABLE;INJECTION20MG/MLDiscontinued
VASOXYLMETHOXAMINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLDiscontinued