FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
761384BLAABBVIE INC001EMRELISVIAL;SINGLE-DOSE20MGTELISOTUZUMAB VEDOTIN-TLLV2025-05-14PrescriptionNo
002EMRELISVIAL;SINGLE-DOSE100MGTELISOTUZUMAB VEDOTIN-TLLV2025-05-14PrescriptionNo
217906NDAABBVIE001EMBLAVEOPOWDER;INTRAVENOUSEQ 0.5GM BASE/VIAL;1.5GM/VIALAVIBACTAM SODIUM; AZTREONAM2025-02-07PrescriptionYes
216962NDAABBVIE001VYALEVSOLUTION;SUBCUTANEOUS120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)FOSCARBIDOPA; FOSLEVODOPA2024-10-16PrescriptionYes
218347NDAABBVIE001RINVOQ LQSOLUTION;ORAL1MG/MLUPADACITINIB2024-04-26PrescriptionYes
761262BLAABBVIE INC001SKYRIZIINJECTABLE;INTRAVENOUS600MG/VIALRISANKIZUMAB-RZAA2022-06-16PrescriptionNo
214028NDAABBVIE001VUITYSOLUTION;OPHTHALMIC1.25%PILOCARPINE HYDROCHLORIDE2021-10-28PrescriptionYes
215206NDAABBVIE001QULIPTATABLET;ORAL10MGATOGEPANT2021-09-28PrescriptionNo
002QULIPTATABLET;ORAL30MGATOGEPANT2021-09-28PrescriptionNo
003QULIPTATABLET;ORAL60MGATOGEPANT2021-09-28PrescriptionYes
215110NDAABBVIE001MAVYRETPELLETS;ORAL50MG;20MG/PACKETGLECAPREVIR; PIBRENTASVIR2021-06-10PrescriptionYes
213388NDAABBVIE001ORIAHNN (COPACKAGED)CAPSULE;ORALEQ 300MG BASE,1MG,0.5MG; EQ 300MG BASEELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM2020-05-29PrescriptionYes
211911NDAABBVIE001DURYSTAIMPLANT;OPHTHALMIC10MCGBIMATOPROST2020-03-04PrescriptionYes
211765NDAABBVIE001UBRELVYTABLET;ORAL50MGUBROGEPANT2019-12-23PrescriptionNo
002UBRELVYTABLET;ORAL100MGUBROGEPANT2019-12-23PrescriptionYes
211675NDAABBVIE001RINVOQTABLET, EXTENDED RELEASE;ORAL15MGUPADACITINIB2019-08-16PrescriptionNo
002RINVOQTABLET, EXTENDED RELEASE;ORAL30MGUPADACITINIB2019-08-16PrescriptionNo
003RINVOQTABLET, EXTENDED RELEASE;ORAL45MGUPADACITINIB2019-08-16PrescriptionYes
761105BLAABBVIE INC001SKYRIZIINJECTABLE;INJECTION75MG/0.83MLRISANKIZUMAB-RZAA2019-04-23PrescriptionNo
002SKYRIZIINJECTABLE;INJECTION150MG/MLRISANKIZUMAB-RZAA2019-04-23PrescriptionNo
210450NDAABBVIE001ORILISSATABLET;ORALEQ 150MG BASEELAGOLIX SODIUM2018-07-23PrescriptionNo
002ORILISSATABLET;ORALEQ 200MG BASEELAGOLIX SODIUM2018-07-23PrescriptionYes
209394NDAABBVIE001MAVYRETTABLET;ORAL100MG;40MGGLECAPREVIR; PIBRENTASVIR2017-08-03PrescriptionYes
209512NDAABBVIE001NORVIRPOWDER;ORAL100MG/PACKETRITONAVIR2017-06-07PrescriptionYes
208624NDAABBVIE001VIEKIRA XRTABLET, EXTENDED RELEASE;ORALEQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR2016-07-22DiscontinuedNo
206302NDAABBVIE001BYVALSONTABLET;ORALEQ 5MG BASE;80MGNEBIVOLOL HYDROCHLORIDE; VALSARTAN2016-06-03DiscontinuedNo
208573NDAABBVIE001VENCLEXTATABLET;ORAL10MGVENETOCLAX2016-04-11PrescriptionNo
002VENCLEXTATABLET;ORAL50MGVENETOCLAX2016-04-11PrescriptionNo
003VENCLEXTATABLET;ORAL100MGVENETOCLAX2016-04-11PrescriptionYes
204370NDAABBVIE001VRAYLARCAPSULE;ORALEQ 1.5MG BASECARIPRAZINE HYDROCHLORIDE2015-09-17PrescriptionYes
002VRAYLARCAPSULE;ORALEQ 3MG BASECARIPRAZINE HYDROCHLORIDE2015-09-17PrescriptionNo
003VRAYLARCAPSULE;ORALEQ 4.5MG BASECARIPRAZINE HYDROCHLORIDE2015-09-17PrescriptionNo
004VRAYLARCAPSULE;ORALEQ 6MG BASECARIPRAZINE HYDROCHLORIDE2015-09-17PrescriptionNo
207931NDAABBVIE001TECHNIVIETABLET;ORAL12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OMBITASVIR; PARITAPREVIR; RITONAVIR2015-07-24DiscontinuedNo
206940NDAABBVIE001VIBERZITABLET;ORAL75MGELUXADOLINE2015-05-27PrescriptionNo
002VIBERZITABLET;ORAL100MGELUXADOLINE2015-05-27PrescriptionYes
206333NDAABBVIE001KYBELLASOLUTION;SUBCUTANEOUS20MG/2ML (10MG/ML)DEOXYCHOLIC ACID2015-04-29PrescriptionYes
206494NDAABBVIE001AVYCAZPOWDER;INTRAVENOUSEQ 0.5GM BASE;2GM/VIALAVIBACTAM SODIUM; CEFTAZIDIME2015-02-25PrescriptionYes
203952NDAABBVIE001DUOPASUSPENSION;ENTERAL4.63MG/ML;20MG/MLCARBIDOPA; LEVODOPA2015-01-09PrescriptionYes
206439NDAABBVIE001NAMZARICCAPSULE, EXTENDED RELEASE;ORAL10MG;14MGDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE2014-12-23PrescriptionNo
002NAMZARICCAPSULE, EXTENDED RELEASE;ORAL10MG;28MGDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE2014-12-23PrescriptionYes
003NAMZARICCAPSULE, EXTENDED RELEASE;ORAL10MG;7MGDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE2014-12-23PrescriptionNo
004NAMZARICCAPSULE, EXTENDED RELEASE;ORAL10MG;21MGDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE2014-12-23PrescriptionNo
206619NDAABBVIE001VIEKIRA PAK (COPACKAGED)TABLET;ORALEQ 250MG BASE;12.5MG, 75MG, 50MGDASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR2014-12-19DiscontinuedNo
021883NDAABBVIE001DALVANCEPOWDER;INTRAVENOUSEQ 500MG BASE/VIALDALBAVANCIN HYDROCHLORIDE2014-05-23PrescriptionYes
204168NDAABBVIE001FETZIMACAPSULE, EXTENDED RELEASE;ORALEQ 20MG BASELEVOMILNACIPRAN HYDROCHLORIDE2013-07-25PrescriptionNo
002FETZIMACAPSULE, EXTENDED RELEASE;ORALEQ 40MG BASELEVOMILNACIPRAN HYDROCHLORIDE2013-07-25PrescriptionNo
003FETZIMACAPSULE, EXTENDED RELEASE;ORALEQ 80MG BASELEVOMILNACIPRAN HYDROCHLORIDE2013-07-25PrescriptionNo
004FETZIMACAPSULE, EXTENDED RELEASE;ORALEQ 120MG BASELEVOMILNACIPRAN HYDROCHLORIDE2013-07-25PrescriptionYes
204412NDAABBVIE001DELZICOLCAPSULE, DELAYED RELEASE;ORAL400MGMESALAMINE2013-02-01DiscontinuedNo
202211NDAABBVIE001OXYTROL FOR WOMENFILM, EXTENDED RELEASE;TRANSDERMAL3.9MG/24HROXYBUTYNIN2013-01-25Over-the-counterYes
203696NDAABBVIE ENDOCRINE001LUPANETA PACKINJECTABLE, TABLET;INTRAMUSCULAR, ORAL3.75MG/VIAL,N/A;N/A,5MGLEUPROLIDE ACETATE; NORETHINDRONE ACETATE2012-12-14DiscontinuedNo
002LUPANETA PACKINJECTABLE, TABLET;INTRAMUSCULAR, ORAL11.25MG/VIAL,N/A;N/A,5MGLEUPROLIDE ACETATE; NORETHINDRONE ACETATE2012-12-14DiscontinuedNo
202811NDAABBVIE001LINZESSCAPSULE;ORAL145MCGLINACLOTIDE2012-08-30PrescriptionYes
002LINZESSCAPSULE;ORAL290MCGLINACLOTIDE2012-08-30PrescriptionNo
003LINZESSCAPSULE;ORAL72MCGLINACLOTIDE2012-08-30PrescriptionYes
021359NDAABBVIE001RECTIVOINTMENT;INTRA-ANAL0.4%NITROGLYCERIN2011-06-21PrescriptionYes
022567NDAABBVIE001VIIBRYDTABLET;ORAL10MGVILAZODONE HYDROCHLORIDE2011-01-21PrescriptionYes
002VIIBRYDTABLET;ORAL20MGVILAZODONE HYDROCHLORIDE2011-01-21PrescriptionNo
003VIIBRYDTABLET;ORAL40MGVILAZODONE HYDROCHLORIDE2011-01-21PrescriptionNo
200327NDAABBVIE001TEFLAROPOWDER;INTRAVENOUS400MG/VIALCEFTAROLINE FOSAMIL2010-10-29PrescriptionYes
002TEFLAROPOWDER;INTRAVENOUS600MG/VIALCEFTAROLINE FOSAMIL2010-10-29PrescriptionYes
022184NDAABBVIE001LUMIGANSOLUTION/DROPS;OPHTHALMIC0.01%BIMATOPROST2010-08-31PrescriptionYes
022134NDAABBVIE001LASTACAFTSOLUTION/DROPS;OPHTHALMIC0.25%ALCAFTADINE2010-07-28Over-the-counterYes
022525NDAABBVIE001NAMENDA XRCAPSULE, EXTENDED RELEASE;ORAL7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MEMANTINE HYDROCHLORIDE2010-06-21DiscontinuedNo
002NAMENDA XRCAPSULE, EXTENDED RELEASE;ORAL14MGMEMANTINE HYDROCHLORIDE2010-06-21DiscontinuedNo
003NAMENDA XRCAPSULE, EXTENDED RELEASE;ORAL21MGMEMANTINE HYDROCHLORIDE2010-06-21DiscontinuedNo
004NAMENDA XRCAPSULE, EXTENDED RELEASE;ORAL28MGMEMANTINE HYDROCHLORIDE2010-06-21DiscontinuedNo
022548NDAABBVIE001ZYMAXIDSOLUTION/DROPS;OPHTHALMIC0.5%GATIFLOXACIN2010-05-18PrescriptionYes
022417NDAABBVIE001NORVIRTABLET;ORAL100MGRITONAVIR2010-02-10PrescriptionYes
022427NDAABBVIE001ACUVAILSOLUTION/DROPS;OPHTHALMIC0.45%KETOROLAC TROMETHAMINE2009-07-22PrescriptionYes
022315NDAABBVIE001OZURDEXIMPLANT;INTRAVITREAL0.7MGDEXAMETHASONE2009-06-17PrescriptionYes
020725BLAABBVIE001CREONCAPSULE, DELAYED RELEASE;ORAL30,000USP UNITS;6,000USP UNITS;19,000USP UNITSPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)2009-04-30PrescriptionNo
002CREONCAPSULE, DELAYED RELEASE;ORAL60,000USP UNITS;12,000USP UNITS;38,000USP UNITSPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)2009-04-30PrescriptionNo
003CREONCAPSULE, DELAYED RELEASE;ORAL120,000USP UNITS;24,000USP UNITS;76,000USP UNITSPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)2009-04-30PrescriptionNo
004CREONCAPSULE, DELAYED RELEASE;ORAL15,000USP UNITS;3,000USP UNITS;9,500USP UNITSPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)2009-04-30PrescriptionNo
005CREONCAPSULE, DELAYED RELEASE;ORAL180,000USP UNITS;36,000USP UNITS;114,000USP UNITSPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)2009-04-30PrescriptionNo
022204NDAABBVIE001GELNIQUEGEL;TRANSDERMAL10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OXYBUTYNIN CHLORIDE2009-01-27DiscontinuedNo
022256NDAABBVIE001SAVELLATABLET;ORAL12.5MGMILNACIPRAN HYDROCHLORIDE2009-01-14PrescriptionNo
002SAVELLATABLET;ORAL25MGMILNACIPRAN HYDROCHLORIDE2009-01-14PrescriptionNo
003SAVELLATABLET;ORAL50MGMILNACIPRAN HYDROCHLORIDE2009-01-14PrescriptionYes
004SAVELLATABLET;ORAL100MGMILNACIPRAN HYDROCHLORIDE2009-01-14PrescriptionNo
022369NDAABBVIE001LATISSESOLUTION/DROPS;TOPICAL0.03%BIMATOPROST2008-12-24PrescriptionYes
022224NDAABBVIE001TRILIPIXCAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACIDCHOLINE FENOFIBRATE2008-12-15DiscontinuedNo
002TRILIPIXCAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACIDCHOLINE FENOFIBRATE2008-12-15DiscontinuedNo
022206NDAABBVIE001RAPAFLOCAPSULE;ORAL4MGSILODOSIN2008-10-08DiscontinuedNo
002RAPAFLOCAPSULE;ORAL8MGSILODOSIN2008-10-08DiscontinuedNo
021830NDAABBVIE001ASACOL HDTABLET, DELAYED RELEASE;ORAL800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MESALAMINE2008-05-29DiscontinuedNo
022267NDAABBVIE INC001DEPAKOTE ERTABLET, EXTENDED RELEASE; ORAL250MGDIVALPROEX SODIUM2008-03-24PrescriptionNo
002DEPAKOTE ERTABLET, EXTENDED RELEASE; ORAL500MGDIVALPROEX SODIUM2008-03-24PrescriptionNo
021398NDAABBVIE001COMBIGANSOLUTION/DROPS;OPHTHALMIC0.2%;EQ 0.5% BASEBRIMONIDINE TARTRATE; TIMOLOL MALEATE2007-10-30PrescriptionYes
021906NDAABBVIE001KALETRATABLET;ORAL200MG;50MGLOPINAVIR; RITONAVIR2005-10-28PrescriptionYes
002KALETRATABLET;ORAL100MG;25MGLOPINAVIR; RITONAVIR2005-10-28PrescriptionNo
021770NDAABBVIE001ALPHAGAN PSOLUTION/DROPS;OPHTHALMIC0.1%BRIMONIDINE TARTRATE2005-08-19PrescriptionYes
021794NDAABBVIE001ACZONEGEL;TOPICAL5%DAPSONE2005-07-07PrescriptionYes
021606NDAABBVIE001ZEMPLARCAPSULE;ORAL1MCGPARICALCITOL2005-05-26PrescriptionNo
002ZEMPLARCAPSULE;ORAL2MCGPARICALCITOL2005-05-26PrescriptionNo
003ZEMPLARCAPSULE;ORAL4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**PARICALCITOL2005-05-26DiscontinuedNo
021513NDAABBVIE001ENABLEXTABLET, EXTENDED RELEASE;ORALEQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**DARIFENACIN HYDROBROMIDE2004-12-22DiscontinuedNo
002ENABLEXTABLET, EXTENDED RELEASE;ORALEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**DARIFENACIN HYDROBROMIDE2004-12-22DiscontinuedNo
021656NDAABBVIE001TRICORTABLET;ORAL48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FENOFIBRATE2004-11-05DiscontinuedNo
002TRICORTABLET;ORAL145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FENOFIBRATE2004-11-05DiscontinuedNo
021487NDAABBVIE001NAMENDATABLET;ORAL5MGMEMANTINE HYDROCHLORIDE2003-10-16PrescriptionNo
002NAMENDATABLET;ORAL10MGMEMANTINE HYDROCHLORIDE2003-10-16PrescriptionYes
021528NDAABBVIE001ACULAR LSSOLUTION/DROPS;OPHTHALMIC0.4%KETOROLAC TROMETHAMINE2003-05-30PrescriptionYes
125057BLAABBVIE INC001HUMIRASYRINGE40MG/0.8MLADALIMUMAB2002-12-31PrescriptionNo
002HUMIRAVIAL40MG/0.8MLADALIMUMAB2002-12-31PrescriptionNo
050790NDAABBVIE001RESTASISEMULSION;OPHTHALMIC0.05%CYCLOSPORINE2002-12-23PrescriptionYes
002RESTASIS MULTIDOSEEMULSION;OPHTHALMIC0.05%CYCLOSPORINE2002-12-23PrescriptionYes
021365NDAABBVIE001LEXAPROSOLUTION;ORALEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ESCITALOPRAM OXALATE2002-11-27DiscontinuedNo
021323NDAABBVIE001LEXAPROTABLET;ORALEQ 5MG BASEESCITALOPRAM OXALATE2002-08-14PrescriptionNo
002LEXAPROTABLET;ORALEQ 10MG BASEESCITALOPRAM OXALATE2002-08-14PrescriptionNo
003LEXAPROTABLET;ORALEQ 20MG BASEESCITALOPRAM OXALATE2002-08-14PrescriptionYes
021402NDAABBVIE001SYNTHROIDTABLET;ORAL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
002SYNTHROIDTABLET;ORAL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
003SYNTHROIDTABLET;ORAL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
004SYNTHROIDTABLET;ORAL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
005SYNTHROIDTABLET;ORAL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
006SYNTHROIDTABLET;ORAL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
007SYNTHROIDTABLET;ORAL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
008SYNTHROIDTABLET;ORAL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
009SYNTHROIDTABLET;ORAL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
010SYNTHROIDTABLET;ORAL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
011SYNTHROIDTABLET;ORAL0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionYes
012SYNTHROIDTABLET;ORAL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumLEVOTHYROXINE SODIUM2002-07-24PrescriptionNo
075729ANDAABBVIE001FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINERINJECTABLE;INJECTION0.4MG/MLFAMOTIDINE2001-12-17DiscontinuedNo
021268NDAABBVIE001TEVETEN HCTTABLET;ORAL600MG;12.5MGEPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE2001-11-01DiscontinuedNo
002TEVETEN HCTTABLET;ORAL600MG;25MGEPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE2001-11-01DiscontinuedNo
021203NDAABBVIE001TRICORTABLET;ORAL54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FENOFIBRATE2001-09-04DiscontinuedNo
003TRICORTABLET;ORAL160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FENOFIBRATE2001-09-04DiscontinuedNo
021262NDAABBVIE001ALPHAGAN PSOLUTION/DROPS;OPHTHALMIC0.15%BRIMONIDINE TARTRATE2001-03-16PrescriptionYes
021275NDAABBVIE001LUMIGANSOLUTION/DROPS;OPHTHALMIC0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BIMATOPROST2001-03-16DiscontinuedNo
021252NDAABBVIE001CANASASUPPOSITORY;RECTAL500MGMESALAMINE2001-01-05DiscontinuedNo
002CANASASUPPOSITORY;RECTAL1GMMESALAMINE2001-01-05PrescriptionYes
021226NDAABBVIE001KALETRACAPSULE;ORAL133.3MG;33.3MGLOPINAVIR; RITONAVIR2000-09-15DiscontinuedNo
021251NDAABBVIE001KALETRASOLUTION;ORAL80MG/ML;20MG/MLLOPINAVIR; RITONAVIR2000-09-15PrescriptionYes
021168NDAABBVIE001DEPAKOTE ERTABLET, EXTENDED RELEASE;ORALEQ 500MG VALPROIC ACIDDIVALPROEX SODIUM2000-08-04PrescriptionNo
002DEPAKOTE ERTABLET, EXTENDED RELEASE;ORALEQ 250MG VALPROIC ACIDDIVALPROEX SODIUM2000-08-04PrescriptionNo
021145NDAABBVIE001VANIQACREAM;TOPICAL13.9%EFLORNITHINE HYDROCHLORIDE2000-07-27DiscontinuedNo
065003ANDAABBVIE001GENGRAFCAPSULE;ORAL25MGCYCLOSPORINE2000-05-12PrescriptionNo
002GENGRAFCAPSULE;ORAL50MGCYCLOSPORINE2000-05-12DiscontinuedNo
003GENGRAFCAPSULE;ORAL100MGCYCLOSPORINE2000-05-12PrescriptionNo
050775NDAABBVIE001BIAXIN XLTABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CLARITHROMYCIN2000-03-03DiscontinuedNo
065025ANDAABBVIE001CYCLOSPORINESOLUTION;ORAL100MG/MLCYCLOSPORINE2000-03-03DiscontinuedNo
075114ANDAABBVIE001ACYCLOVIRINJECTABLE;INJECTIONEQ 50MG BASE/MLACYCLOVIR SODIUM1999-07-26DiscontinuedNo
020945NDAABBVIE001NORVIRCAPSULE;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**RITONAVIR1999-06-29DiscontinuedNo
020822NDAABBVIE001CELEXATABLET;ORALEQ 10MG BASECITALOPRAM HYDROBROMIDE1998-07-17PrescriptionNo
002CELEXATABLET;ORALEQ 20MG BASECITALOPRAM HYDROBROMIDE1998-07-17PrescriptionNo
003CELEXATABLET;ORALEQ 40MG BASECITALOPRAM HYDROBROMIDE1998-07-17PrescriptionYes
004CELEXATABLET;ORALEQ 60MG BASECITALOPRAM HYDROBROMIDE1998-07-17DiscontinuedNo
020819NDAABBVIE001ZEMPLARSOLUTION;INTRAVENOUS0.005MG/ML (0.005MG/ML)PARICALCITOL1998-04-17PrescriptionYes
002ZEMPLARSOLUTION;INTRAVENOUS0.002MG/ML (0.002MG/ML)PARICALCITOL1998-04-17PrescriptionYes
003ZEMPLARSOLUTION;INTRAVENOUS0.01MG/2ML (0.005MG/ML)PARICALCITOL1998-04-17PrescriptionYes
020738NDAABBVIE004TEVETENTABLET;ORALEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**EPROSARTAN MESYLATE1997-12-22DiscontinuedNo
005TEVETENTABLET;ORALEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**EPROSARTAN MESYLATE1997-12-22DiscontinuedNo
006TEVETENTABLET;ORALEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**EPROSARTAN MESYLATE1997-12-22DiscontinuedNo
020675NDAABBVIE001URSO 250TABLET;ORAL250MGURSODIOL1997-12-10DiscontinuedNo
002URSO FORTETABLET;ORAL500MGURSODIOL1997-12-10DiscontinuedNo
050739NDAABBVIE001OMNICEFCAPSULE;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CEFDINIR1997-12-04DiscontinuedNo
050749NDAABBVIE001OMNICEFFOR SUSPENSION;ORAL125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CEFDINIR1997-12-04DiscontinuedNo
002OMNICEFFOR SUSPENSION;ORAL250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CEFDINIR1997-12-04DiscontinuedNo
020716NDAABBVIE001VICOPROFENTABLET;ORAL7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**HYDROCODONE BITARTRATE; IBUPROFEN1997-09-23DiscontinuedNo
020701NDAABBVIE001CRINONEGEL;VAGINAL4%PROGESTERONE1997-07-31PrescriptionYes
002CRINONEGEL;VAGINAL8%PROGESTERONE1997-07-31PrescriptionYes
020381NDAABBVIE001NIASPANTABLET, EXTENDED RELEASE;ORAL375MGNIACIN1997-07-28DiscontinuedNo
002NIASPANTABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**NIACIN1997-07-28DiscontinuedNo
003NIASPANTABLET, EXTENDED RELEASE;ORAL750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**NIACIN1997-07-28DiscontinuedNo
004NIASPANTABLET, EXTENDED RELEASE;ORAL1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**NIACIN1997-07-28DiscontinuedNo
005NIASPAN TITRATION STARTER PACKTABLET, EXTENDED RELEASE;ORAL375MG;500MG;750MGNIACIN1997-07-28DiscontinuedNo
020600NDAABBVIE001TAZORACGEL;TOPICAL0.05%TAZAROTENE1997-06-13PrescriptionYes
002TAZORACGEL;TOPICAL0.1%TAZAROTENE1997-06-13PrescriptionYes
074638ANDAABBVIE001IOPAMIDOL-300INJECTABLE;INJECTION61%IOPAMIDOL1997-04-30DiscontinuedNo
020708NDAABBVIE ENDOCRINE INC001LUPRON DEPOTINJECTABLE;INJECTION11.25MGLEUPROLIDE ACETATE1997-03-07PrescriptionYes
020593NDAABBVIE001DEPACONINJECTABLE;INJECTIONEQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**VALPROATE SODIUM1996-12-30DiscontinuedNo
020655NDAABBVIE001ALORAFILM, EXTENDED RELEASE;TRANSDERMAL0.05MG/24HRESTRADIOL1996-12-20DiscontinuedNo
002ALORAFILM, EXTENDED RELEASE;TRANSDERMAL0.075MG/24HRESTRADIOL1996-12-20DiscontinuedNo
003ALORAFILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/24HRESTRADIOL1996-12-20DiscontinuedNo
004ALORAFILM, EXTENDED RELEASE;TRANSDERMAL0.025MG/24HRESTRADIOL1996-12-20DiscontinuedNo
020591NDAABBVIE001TARKATABLET, EXTENDED RELEASE;ORAL2MG;180MGTRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE1996-10-22DiscontinuedNo
002TARKATABLET, EXTENDED RELEASE;ORAL4MG;240MGTRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE1996-10-22DiscontinuedNo
003TARKATABLET, EXTENDED RELEASE;ORAL1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE1996-10-22DiscontinuedNo
004TARKATABLET, EXTENDED RELEASE;ORAL2MG;240MGTRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE1996-10-22DiscontinuedNo
040117ANDAABBVIE001VICODIN HPTABLET;ORAL660MG;10MGACETAMINOPHEN; HYDROCODONE BITARTRATE1996-09-23DiscontinuedNo
020528NDAABBVIE001MAVIKTABLET;ORAL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TRANDOLAPRIL1996-04-26DiscontinuedNo
002MAVIKTABLET;ORAL2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TRANDOLAPRIL1996-04-26DiscontinuedNo
003MAVIKTABLET;ORAL4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TRANDOLAPRIL1996-04-26DiscontinuedNo
020659NDAABBVIE001NORVIRSOLUTION;ORAL80MG/MLRITONAVIR1996-03-01DiscontinuedNo
020517NDAABBVIE ENDOCRINE INC001LUPRON DEPOTINJECTABLE;INJECTION22.5MGLEUPROLIDE ACETATE1995-12-22PrescriptionNo
002LUPRON DEPOTINJECTABLE;INJECTION30MGLEUPROLIDE ACETATE1995-12-22PrescriptionYes
003LUPRON DEPOTINJECTABLE;INJECTION45MGLEUPROLIDE ACETATE1995-12-22PrescriptionYes
020551NDAABBVIE001NIMBEXINJECTABLE;INJECTIONEQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CISATRACURIUM BESYLATE1995-12-15DiscontinuedNo
002NIMBEX PRESERVATIVE FREEINJECTABLE;INJECTIONEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CISATRACURIUM BESYLATE1995-12-15DiscontinuedNo
003NIMBEX PRESERVATIVE FREEINJECTABLE;INJECTIONEQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CISATRACURIUM BESYLATE1995-12-15DiscontinuedNo
020489NDAABBVIE001ANDRODERMFILM, EXTENDED RELEASE;TRANSDERMAL2.5MG/24HRTESTOSTERONE1995-09-29DiscontinuedNo
002ANDRODERMFILM, EXTENDED RELEASE;TRANSDERMAL5MG/24HRTESTOSTERONE1995-09-29DiscontinuedNo
003ANDRODERMFILM, EXTENDED RELEASE;TRANSDERMAL2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TESTOSTERONE1995-09-29DiscontinuedNo
004ANDRODERMFILM, EXTENDED RELEASE;TRANSDERMAL4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TESTOSTERONE1995-09-29DiscontinuedNo
020478NDAABBVIE001ULTANELIQUID;INHALATION100%SEVOFLURANE1995-06-07PrescriptionYes
019943NDAABBVIE ENDOCRINE INC002LUPRON DEPOTINJECTABLE; INJECTION3.75MGLEUPROLIDE ACETATE1995-03-30PrescriptionNo
019304NDAABBVIE001LIPIDILCAPSULE;ORAL100MGFENOFIBRATE1993-12-31DiscontinuedNo
002TRICOR (MICRONIZED)CAPSULE;ORAL67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FENOFIBRATE1993-12-31DiscontinuedNo
003TRICOR (MICRONIZED)CAPSULE;ORAL134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FENOFIBRATE1993-12-31DiscontinuedNo
004TRICOR (MICRONIZED)CAPSULE;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FENOFIBRATE1993-12-31DiscontinuedNo
050698NDAABBVIE001BIAXINFOR SUSPENSION;ORAL125MG/5MLCLARITHROMYCIN1993-12-23DiscontinuedNo
002BIAXINFOR SUSPENSION;ORAL250MG/5MLCLARITHROMYCIN1993-12-23DiscontinuedNo
003BIAXINFOR SUSPENSION;ORAL187MG/5MLCLARITHROMYCIN1993-12-23DiscontinuedNo
050697NDAABBVIE INC001BIAXIN XLTABLET;ORAL250MGCLARITHROMYCIN1993-12-23PrescriptionNo
002BIAXIN XLTABLET;ORAL500MGCLARITHROMYCIN1993-12-23PrescriptionNo
019183NDAABBVIE001CARAFATESUSPENSION;ORAL1GM/10MLSUCRALFATE1993-12-16PrescriptionYes
020263NDAABBVIE ENDOCRINE INC002LUPRON DEPOT-PED KITPOWDER;INTRAMUSCULAR7.5MGLEUPROLIDE ACETATE1993-04-16PrescriptionYes
003LUPRON DEPOT-PED KITPOWDER;INTRAMUSCULAR3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LEUPROLIDE ACETATE1993-04-16DiscontinuedNo
004LUPRON DEPOT-PED KITPOWDER;INTRAMUSCULAR7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LEUPROLIDE ACETATE1993-04-16DiscontinuedNo
005LUPRON DEPOT-PED KITPOWDER;INTRAMUSCULAR11.25MGLEUPROLIDE ACETATE1993-04-16PrescriptionYes
006LUPRON DEPOT-PED KITPOWDER;INTRAMUSCULAR15MGLEUPROLIDE ACETATE1993-04-16PrescriptionYes
007LUPRON DEPOT-PED KITPOWDER;INTRAMUSCULAR11.25MGLEUPROLIDE ACETATE1993-04-16PrescriptionYes
008LUPRON DEPOT-PED KITPOWDER;INTRAMUSCULAR30MGLEUPROLIDE ACETATE1993-04-16PrescriptionYes
009LUPRON DEPOT-PED KITPOWDER;INTRAMUSCULAR45MGLEUPROLIDE ACETATE1993-04-16PrescriptionYes
020200NDAABBVIE001NALBUPHINE HYDROCHLORIDEINJECTABLE;INJECTION1.5MG/MLNALBUPHINE HYDROCHLORIDE1993-03-12DiscontinuedNo
019700NDAABBVIE001ACULARSOLUTION/DROPS;OPHTHALMIC0.5%KETOROLAC TROMETHAMINE1992-11-09PrescriptionYes
020098NDAABBVIE001MIVACRONSOLUTION;INTRAVENOUSEQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MIVACURIUM CHLORIDE1992-01-22DiscontinuedNo
004MIVACRONSOLUTION;INTRAVENOUSEQ 10MG BASE/5ML (EQ 2MG BASE/ML)MIVACURIUM CHLORIDE1992-01-22DiscontinuedNo
005MIVACRONSOLUTION;INTRAVENOUSEQ 20MG BASE/10ML (EQ 2MG BASE/ML)MIVACURIUM CHLORIDE1992-01-22DiscontinuedNo
002MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINERINJECTABLE;INJECTIONEQ 0.5MG BASE/MLMIVACURIUM CHLORIDE1992-01-22DiscontinuedNo
003MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINERINJECTABLE;INJECTIONEQ 50MG BASE/100MLMIVACURIUM CHLORIDE1992-01-22DiscontinuedNo
050662NDAABBVIE001BIAXINTABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CLARITHROMYCIN1991-10-31DiscontinuedNo
002BIAXINTABLET;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CLARITHROMYCIN1991-10-31DiscontinuedNo
020032BLAABBVIE001SURVANTASUSPENSION;INTRATRACHEAL25MG/MLBERACTANT1991-07-01PrescriptionNo
019946NDAABBVIE001NUROMAXINJECTABLE;INJECTIONEQ 1MG BASE/MLDOXACURIUM CHLORIDE1991-03-07DiscontinuedNo
020011NDAABBVIE ENDOCRINE INC001LUPRON DEPOTINJECTABLE;INJECTION3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LEUPROLIDE ACETATE1990-10-22DiscontinuedNo
002LUPRON DEPOTINJECTABLE;INJECTION3.75MGLEUPROLIDE ACETATE1990-10-22PrescriptionYes
019680NDAABBVIE001DEPAKOTECAPSULE, DELAYED REL PELLETS;ORALEQ 125MG VALPROIC ACIDDIVALPROEX SODIUM1989-09-12PrescriptionYes
019732NDAABBVIE ENDOCRINE INC001LUPRON DEPOTINJECTABLE;INJECTION7.5MGLEUPROLIDE ACETATE1989-01-26PrescriptionYes
019204NDAABBVIE001CARTROLTABLET;ORAL2.5MGCARTEOLOL HYDROCHLORIDE1988-12-28DiscontinuedNo
002CARTROLTABLET;ORAL5MGCARTEOLOL HYDROCHLORIDE1988-12-28DiscontinuedNo
003CARTROLTABLET;ORAL10MGCARTEOLOL HYDROCHLORIDE1988-12-28DiscontinuedNo
089736ANDAABBVIE001VICODIN ESTABLET;ORAL750MG;7.5MGACETAMINOPHEN; HYDROCODONE BITARTRATE1988-12-09DiscontinuedNo
071295ANDAABBVIE001ATROPINESOLUTION;INTRAMUSCULAREQ 2MG SULFATE/0.7MLATROPINE1987-01-30DiscontinuedNo
018874NDAABBVIE001CALCIJEXINJECTABLE;INJECTION0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CALCITRIOL1986-09-25DiscontinuedNo
002CALCIJEXINJECTABLE;INJECTION0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CALCITRIOL1986-09-25DiscontinuedNo
019216NDAABBVIE001FML FORTESUSPENSION/DROPS;OPHTHALMIC0.25%FLUOROMETHOLONE1986-04-23PrescriptionYes
019010NDAABBVIE ENDOCRINE INC001LUPRONSOLUTION;SUBCUTANEOUS14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LEUPROLIDE ACETATE1985-04-09DiscontinuedNo
018723NDAABBVIE001DEPAKOTETABLET, DELAYED RELEASE;ORALEQ 250MG VALPROIC ACIDDIVALPROEX SODIUM1983-03-10PrescriptionNo
002DEPAKOTETABLET, DELAYED RELEASE;ORALEQ 500MG VALPROIC ACIDDIVALPROEX SODIUM1983-03-10PrescriptionYes
003DEPAKOTETABLET, DELAYED RELEASE;ORALEQ 125MG VALPROIC ACIDDIVALPROEX SODIUM1983-03-10PrescriptionNo
088058ANDAABBVIE001VICODINTABLET;ORAL500MG;5MGACETAMINOPHEN; HYDROCODONE BITARTRATE1983-01-07DiscontinuedNo
018117NDAABBVIE001AZMACORTAEROSOL, METERED;INHALATION0.1MG/INHTRIAMCINOLONE ACETONIDE1982-04-23DiscontinuedNo
018333NDAABBVIE001CARAFATETABLET;ORAL1GMSUCRALFATE1981-10-30PrescriptionYes
018450NDAABBVIE001NITROPRESSINJECTABLE;INJECTION50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SODIUM NITROPRUSSIDE1981-09-08DiscontinuedNo
018279NDAABBVIE001K-TABTABLET, EXTENDED RELEASE;ORAL10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POTASSIUM CHLORIDE1980-06-09DiscontinuedNo
002K-TABTABLET, EXTENDED RELEASE;ORAL8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POTASSIUM CHLORIDE1980-06-09DiscontinuedNo
003K-TABTABLET, EXTENDED RELEASE;ORAL20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POTASSIUM CHLORIDE1980-06-09DiscontinuedNo
018081NDAABBVIE001DEPAKENECAPSULE;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**VALPROIC ACID1978-02-28DiscontinuedNo
018082NDAABBVIE001DEPAKENESYRUP;ORAL250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**VALPROIC ACID1978-02-28DiscontinuedNo
017011NDAABBVIE001PRED FORTESUSPENSION/DROPS;OPHTHALMIC1%PREDNISOLONE ACETATE1973-05-30PrescriptionYes
017100NDAABBVIE001PRED MILDSUSPENSION/DROPS;OPHTHALMIC0.12%PREDNISOLONE ACETATE1972-11-10PrescriptionYes
016851NDAABBVIE002FMLSUSPENSION/DROPS;OPHTHALMIC0.1%FLUOROMETHOLONE1972-01-12PrescriptionYes
005932NDAABBVIE012AMINOSOL 5%INJECTABLE;INJECTION5%PROTEIN HYDROLYSATEDiscontinuedNo
087847ANDAABBVIE001ATROPINE AND DEMEROLINJECTABLE;INJECTION0.4MG/ML;75MG/MLATROPINE SULFATE; MEPERIDINE HYDROCHLORIDEDiscontinuedNo
087848ANDAABBVIE001ATROPINE AND DEMEROLINJECTABLE;INJECTION0.4MG/ML;100MG/MLATROPINE SULFATE; MEPERIDINE HYDROCHLORIDEDiscontinuedNo
087853ANDAABBVIE001ATROPINE AND DEMEROLINJECTABLE;INJECTION0.4MG/ML;50MG/MLATROPINE SULFATE; MEPERIDINE HYDROCHLORIDEDiscontinuedNo
006044NDAABBVIE003DIASONE SODIUMTABLET, DELAYED RELEASE;ORAL165MGSULFOXONE SODIUMDiscontinuedNo
008322NDAABBVIE001GEMONILTABLET;ORAL100MGMETHARBITALDiscontinuedNo
006905NDAABBVIE002NORISODRINEPOWDER;INHALATION25%ISOPROTERENOL SULFATEDiscontinuedNo
003NORISODRINEPOWDER;INHALATION10%ISOPROTERENOL SULFATEDiscontinuedNo
004125NDAABBVIE005SULFADIAZINETABLET;ORAL300MGSULFADIAZINEDiscontinuedNo
012302NDAABBVIE002CHOLOXINTABLET;ORAL2MGDEXTROTHYROXINE SODIUM1967-04-14DiscontinuedNo
004CHOLOXINTABLET;ORAL4MGDEXTROTHYROXINE SODIUM1967-04-14DiscontinuedNo
005CHOLOXINTABLET;ORAL1MGDEXTROTHYROXINE SODIUM1967-04-14DiscontinuedNo
006CHOLOXINTABLET;ORAL6MGDEXTROTHYROXINE SODIUM1967-04-14DiscontinuedNo
010021NDAABBVIE002PLACIDYLCAPSULE;ORAL500MGETHCHLORVYNOL1961-05-10DiscontinuedNo
004PLACIDYLCAPSULE;ORAL100MGETHCHLORVYNOL1961-05-10DiscontinuedNo
007PLACIDYLCAPSULE;ORAL200MGETHCHLORVYNOL1961-05-10DiscontinuedNo
010PLACIDYLCAPSULE;ORAL750MGETHCHLORVYNOL1961-05-10DiscontinuedNo
012418NDAABBVIE002AKINETONINJECTABLE;INJECTION5MG/MLBIPERIDEN LACTATE1961-04-20DiscontinuedNo
012524NDAABBVIE001ENDURONTABLET;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**METHYCLOTHIAZIDE1960-10-21DiscontinuedNo
004ENDURONTABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**METHYCLOTHIAZIDE1960-10-21DiscontinuedNo
012148NDAABBVIE001ORETICYL 25TABLET;ORAL0.125MG;25MGDESERPIDINE; HYDROCHLOROTHIAZIDE1959-12-14DiscontinuedNo
003ORETICYL 50TABLET;ORAL0.125MG;50MGDESERPIDINE; HYDROCHLOROTHIAZIDE1959-12-14DiscontinuedNo
002ORETICYL FORTETABLET;ORAL0.25MG;25MGDESERPIDINE; HYDROCHLOROTHIAZIDE1959-12-14DiscontinuedNo
012003NDAABBVIE001AKINETONTABLET;ORAL2MGBIPERIDEN HYDROCHLORIDE1959-09-08DiscontinuedNo
011971NDAABBVIE001ORETICTABLET;ORAL25MGHYDROCHLOROTHIAZIDE1959-07-06DiscontinuedNo
002ORETICTABLET;ORAL50MGHYDROCHLOROTHIAZIDE1959-07-06DiscontinuedNo
010796NDAABBVIE001HARMONYLTABLET;ORAL0.1MGDESERPIDINE1957-04-19DiscontinuedNo
002HARMONYLTABLET;ORAL0.25MGDESERPIDINE1957-04-19DiscontinuedNo
010599NDAABBVIE001TRALTABLET;ORAL25MGHEXOCYCLIUM METHYLSULFATE1957-02-13DiscontinuedNo
008370NDAABBVIE001BENTYLINJECTABLE;INJECTION10MG/MLDICYCLOMINE HYDROCHLORIDE1952-08-13DiscontinuedNo
002BENTYL PRESERVATIVE FREEINJECTABLE;INJECTION10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**DICYCLOMINE HYDROCHLORIDE1952-08-13DiscontinuedNo
007707NDAABBVIE001PHENURONETABLET;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**PHENACEMIDE1951-06-28DiscontinuedNo
006800NDAABBVIE001PARADIONECAPSULE;ORAL300MGPARAMETHADIONE1949-06-15DiscontinuedNo
002PARADIONESOLUTION;ORAL300MG/MLPARAMETHADIONE1949-06-15DiscontinuedNo
003PARADIONECAPSULE;ORAL150MGPARAMETHADIONE1949-06-15DiscontinuedNo
005856NDAABBVIE002TRIDIONESOLUTION;ORAL200MG/5MLTRIMETHADIONE1946-01-25DiscontinuedNo
005TRIDIONECAPSULE;ORAL300MGTRIMETHADIONE1946-01-25DiscontinuedNo
009TRIDIONETABLET;ORAL150MGTRIMETHADIONE1946-01-25DiscontinuedNo
005545NDAABBVIE003DICUMAROLTABLET;ORAL25MGDICUMAROL1944-07-31DiscontinuedNo
004DICUMAROLTABLET;ORAL50MGDICUMAROL1944-07-31DiscontinuedNo
005DICUMAROLTABLET;ORAL100MGDICUMAROL1944-07-31DiscontinuedNo