AbbVie Inc.

AbbVie Inc. (ABBV)

FDA Applications

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

ApplicationProduct NameActive IngredientFormStrengthStatus
BLA761262 - ABBVIE INC
SKYRIZIRISANKIZUMAB-RZAAINJECTABLE;INTRAVENOUS600MG/VIALPrescription
BLA761105 - ABBVIE INC
SKYRIZIRISANKIZUMAB-RZAAINJECTABLE;INJECTION75MG/0.83MLPrescription
SKYRIZIRISANKIZUMAB-RZAAINJECTABLE;INJECTION150MG/MLPrescription
NDA218347 - ABBVIE
RINVOQUPADACITINIBTABLET, EXTENDED RELEASE;ORAL15MGPrescription
RINVOQUPADACITINIBTABLET, EXTENDED RELEASE;ORAL30MGPrescription
RINVOQUPADACITINIBTABLET, EXTENDED RELEASE;ORAL45MGPrescription
RINVOQ LQUPADACITINIBSOLUTION;ORAL1MG/MLPrescription
NDA216962 - ABBVIE
VYALEVFOSCARBIDOPA; FOSLEVODOPASOLUTION;SUBCUTANEOUS120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)Prescription
NDA215206 - ABBVIE
QULIPTAATOGEPANTTABLET;ORAL60MGPrescription
QULIPTAATOGEPANTTABLET;ORAL10MGPrescription
QULIPTAATOGEPANTTABLET;ORAL30MGPrescription
NDA215110 - ABBVIE
MAVYRETGLECAPREVIR; PIBRENTASVIRPELLETS;ORAL50MG;20MG/PACKETPrescription
NDA214660 - ABBVIE INC
NDA214028 - ABBVIE
VUITYPILOCARPINE HYDROCHLORIDESOLUTION;OPHTHALMIC1.25%Prescription
NDA213388 - ABBVIE
ORIAHNN (COPACKAGED)ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUMCAPSULE;ORALEQ 300MG BASE,1MG,0.5MG; EQ 300MG BASEPrescription
NDA211911 - ABBVIE
DURYSTABIMATOPROSTIMPLANT;OPHTHALMIC10MCGPrescription
NDA211765 - ABBVIE
UBRELVYUBROGEPANTTABLET;ORAL50MGPrescription
UBRELVYUBROGEPANTTABLET;ORAL100MGPrescription
NDA211675 - ABBVIE
RINVOQUPADACITINIBTABLET, EXTENDED RELEASE;ORAL45MGPrescription
RINVOQUPADACITINIBTABLET, EXTENDED RELEASE;ORAL30MGPrescription
RINVOQUPADACITINIBTABLET, EXTENDED RELEASE;ORAL15MGPrescription
NDA210450 - ABBVIE
ORILISSAELAGOLIX SODIUMTABLET;ORALEQ 200MG BASEPrescription
ORILISSAELAGOLIX SODIUMTABLET;ORALEQ 150MG BASEPrescription
NDA209512 - ABBVIE
NORVIRRITONAVIRPOWDER;ORAL100MG/PACKETPrescription
NDA209394 - ABBVIE
MAVYRETGLECAPREVIR; PIBRENTASVIRTABLET;ORAL100MG;40MGPrescription
NDA208624 - ABBVIE
VIEKIRA XRDASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIRTABLET, 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RELEASE;ORALEQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA208573 - ABBVIE
VENCLEXTAVENETOCLAXTABLET;ORAL10MGPrescription
VENCLEXTAVENETOCLAXTABLET;ORAL100MGPrescription
VENCLEXTAVENETOCLAXTABLET;ORAL50MGPrescription
NDA207931 - ABBVIE
TECHNIVIEOMBITASVIR; PARITAPREVIR; RITONAVIRTABLET;ORAL12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA206940 - ABBVIE
VIBERZIELUXADOLINETABLET;ORAL75MGPrescription
VIBERZIELUXADOLINETABLET;ORAL100MGPrescription
NDA206619 - ABBVIE
VIEKIRA PAK (COPACKAGED)DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIRTABLET;ORALEQ 250MG BASE;12.5MG, 75MG, 50MGDiscontinued
NDA206494 - ABBVIE
AVYCAZAVIBACTAM SODIUM; CEFTAZIDIMEPOWDER;INTRAVENOUSEQ 0.5GM BASE;2GM/VIALPrescription
NDA206439 - ALLERGAN
NAMZARICDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MG;14MGPrescription
NAMZARICDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MG;28MGPrescription
NAMZARICDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MG;7MGPrescription
NAMZARICDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MG;21MGPrescription
NDA206333 - ABBVIE
KYBELLADEOXYCHOLIC ACIDSOLUTION;SUBCUTANEOUS20MG/2ML (10MG/ML)Prescription
NDA206302 - ABBVIE
BYVALSONNEBIVOLOL HYDROCHLORIDE; VALSARTANTABLET;ORALEQ 5MG BASE;80MGDiscontinued
NDA204412 - ABBVIE
DELZICOLMESALAMINECAPSULE, DELAYED RELEASE;ORAL400MGPrescription
NDA204370 - ABBVIE
VRAYLARCARIPRAZINE HYDROCHLORIDECAPSULE;ORALEQ 1.5MG BASEPrescription
VRAYLARCARIPRAZINE HYDROCHLORIDECAPSULE;ORALEQ 4.5MG BASEPrescription
VRAYLARCARIPRAZINE HYDROCHLORIDECAPSULE;ORALEQ 6MG BASEPrescription
VRAYLARCARIPRAZINE HYDROCHLORIDECAPSULE;ORALEQ 3MG BASEPrescription
NDA204168 - ABBVIE
FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 40MG BASEPrescription
FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 120MG BASEPrescription
FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 20MG BASEPrescription
FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 80MG BASEPrescription
NDA203952 - ABBVIE
DUOPACARBIDOPA; LEVODOPASUSPENSION;ENTERAL4.63MG/ML;20MG/MLPrescription
NDA203696 - ABBVIE ENDOCRINE
LUPANETA PACKLEUPROLIDE ACETATE; NORETHINDRONE ACETATEINJECTABLE, TABLET;INTRAMUSCULAR, ORAL3.75MG/VIAL,N/A;N/A,5MGDiscontinued
LUPANETA PACKLEUPROLIDE ACETATE; NORETHINDRONE ACETATEINJECTABLE, TABLET;INTRAMUSCULAR, ORAL11.25MG/VIAL,N/A;N/A,5MGDiscontinued
NDA202811 - ABBVIE
LINZESSLINACLOTIDECAPSULE;ORAL290MCGPrescription
LINZESSLINACLOTIDECAPSULE;ORAL145MCGPrescription
LINZESSLINACLOTIDECAPSULE;ORAL72MCGPrescription
NDA202211 - ABBVIE
OXYTROL FOR WOMENOXYBUTYNINFILM, EXTENDED RELEASE;TRANSDERMAL3.9MG/24HROver-the-counter
NDA200327 - ABBVIE
TEFLAROCEFTAROLINE FOSAMILPOWDER;INTRAVENOUS600MG/VIALPrescription
TEFLAROCEFTAROLINE FOSAMILPOWDER;INTRAVENOUS400MG/VIALPrescription
BLA125057 - ABBVIE INC
HUMIRAADALIMUMABVIAL40MG/0.8MLPrescription
HUMIRAADALIMUMABSYRINGE40MG/0.8MLPrescription
ANDA089736 - ABBVIE
VICODIN ESACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL750MG;7.5MGDiscontinued
ANDA088058 - ABBVIE
VICODINACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL500MG;5MGDiscontinued
ANDA087853 - ABBVIE
ATROPINE AND DEMEROLATROPINE SULFATE; MEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION0.4MG/ML;50MG/MLDiscontinued
ANDA087848 - ABBVIE
ATROPINE AND DEMEROLATROPINE SULFATE; MEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION0.4MG/ML;100MG/MLDiscontinued
ANDA087847 - ABBVIE
ATROPINE AND DEMEROLATROPINE SULFATE; MEPERIDINE HYDROCHLORIDEINJECTABLE;INJECTION0.4MG/ML;75MG/MLDiscontinued
ANDA075729 - ABBVIE
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINERFAMOTIDINEINJECTABLE;INJECTION0.4MG/MLDiscontinued
ANDA075114 - ABBVIE
ACYCLOVIRACYCLOVIR SODIUMINJECTABLE;INJECTIONEQ 50MG BASE/MLDiscontinued
ANDA074638 - ABBVIE
IOPAMIDOL-300IOPAMIDOLINJECTABLE;INJECTION61%Discontinued
ANDA071295 - ABBVIE
ATROPINEATROPINESOLUTION;INTRAMUSCULAREQ 2MG SULFATE/0.7MLDiscontinued
ANDA065025 - ABBVIE
CYCLOSPORINECYCLOSPORINESOLUTION;ORAL100MG/MLPrescription
ANDA065003 - ABBVIE
GENGRAFCYCLOSPORINECAPSULE;ORAL50MGDiscontinued
GENGRAFCYCLOSPORINECAPSULE;ORAL100MGPrescription
GENGRAFCYCLOSPORINECAPSULE;ORAL25MGPrescription
NDA050790 - ABBVIE
RESTASIS MULTIDOSECYCLOSPORINEEMULSION;OPHTHALMIC0.05%Prescription
RESTASISCYCLOSPORINEEMULSION;OPHTHALMIC0.05%Prescription
NDA050775 - ABBVIE
BIAXIN XLCLARITHROMYCINTABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050749 - ABBVIE
OMNICEFCEFDINIRFOR SUSPENSION;ORAL125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
OMNICEFCEFDINIRFOR SUSPENSION;ORAL250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050739 - ABBVIE
OMNICEFCEFDINIRCAPSULE;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA050698 - ABBVIE
BIAXINCLARITHROMYCINFOR SUSPENSION;ORAL125MG/5MLDiscontinued
BIAXINCLARITHROMYCINFOR SUSPENSION;ORAL250MG/5MLDiscontinued
BIAXINCLARITHROMYCINFOR SUSPENSION;ORAL187MG/5MLDiscontinued
NDA050697 - ABBVIE INC
BIAXIN XLCLARITHROMYCINTABLET;ORAL500MGPrescription
BIAXIN XLCLARITHROMYCINTABLET;ORAL250MGPrescription
NDA050662 - ABBVIE
BIAXINCLARITHROMYCINTABLET;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BIAXINCLARITHROMYCINTABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANDA040117 - ABBVIE
VICODIN HPACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL660MG;10MGDiscontinued
NDA022567 - ABBVIE
VIIBRYDVILAZODONE HYDROCHLORIDETABLET;ORAL10MGPrescription
VIIBRYDVILAZODONE HYDROCHLORIDETABLET;ORAL20MGPrescription
VIIBRYDVILAZODONE HYDROCHLORIDETABLET;ORAL40MGPrescription
NDA022548 - ABBVIE
ZYMAXIDGATIFLOXACINSOLUTION/DROPS;OPHTHALMIC0.5%Prescription
NDA022525 - ABBVIE
NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL14MGDiscontinued
NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL21MGDiscontinued
NAMENDA XRMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL28MGDiscontinued
NDA022427 - ABBVIE
ACUVAILKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.45%Prescription
NDA022417 - ABBVIE
NORVIRRITONAVIRTABLET;ORAL100MGPrescription
NDA022369 - ABBVIE
LATISSEBIMATOPROSTSOLUTION/DROPS;TOPICAL0.03%Prescription
NDA022315 - ABBVIE
OZURDEXDEXAMETHASONEIMPLANT;INTRAVITREAL0.7MGPrescription
NDA022267 - ABBVIE INC
DEPAKOTE ERDIVALPROEX SODIUMTABLET, EXTENDED RELEASE; ORAL250MGPrescription
DEPAKOTE ERDIVALPROEX SODIUMTABLET, EXTENDED RELEASE; ORAL500MGPrescription
NDA022256 - ABBVIE
SAVELLAMILNACIPRAN HYDROCHLORIDETABLET;ORAL12.5MGPrescription
SAVELLAMILNACIPRAN HYDROCHLORIDETABLET;ORAL25MGPrescription
SAVELLAMILNACIPRAN HYDROCHLORIDETABLET;ORAL100MGPrescription
SAVELLAMILNACIPRAN HYDROCHLORIDETABLET;ORAL50MGPrescription
NDA022224 - ABBVIE
TRILIPIXCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACIDPrescription
TRILIPIXCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACIDPrescription
NDA022206 - ABBVIE
RAPAFLOSILODOSINCAPSULE;ORAL4MGPrescription
RAPAFLOSILODOSINCAPSULE;ORAL8MGPrescription
NDA022204 - ABBVIE
GELNIQUEOXYBUTYNIN CHLORIDEGEL;TRANSDERMAL10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA022184 - ABBVIE
LUMIGANBIMATOPROSTSOLUTION/DROPS;OPHTHALMIC0.01%Prescription
NDA022134 - ABBVIE
LASTACAFTALCAFTADINESOLUTION/DROPS;OPHTHALMIC0.25%Over-the-counter
NDA021906 - ABBVIE
KALETRALOPINAVIR; RITONAVIRTABLET;ORAL200MG;50MGPrescription
KALETRALOPINAVIR; RITONAVIRTABLET;ORAL100MG;25MGPrescription
NDA021883 - ABBVIE
DALVANCEDALBAVANCIN HYDROCHLORIDEPOWDER;INTRAVENOUSEQ 500MG BASE/VIALPrescription
NDA021830 - ABBVIE
ASACOL HDMESALAMINETABLET, DELAYED RELEASE;ORAL800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA021794 - ABBVIE
ACZONEDAPSONEGEL;TOPICAL5%Prescription
NDA021770 - ABBVIE
ALPHAGAN PBRIMONIDINE TARTRATESOLUTION/DROPS;OPHTHALMIC0.1%Prescription
NDA021656 - ABBVIE
TRICORFENOFIBRATETABLET;ORAL48MGDiscontinued
TRICORFENOFIBRATETABLET;ORAL145MGDiscontinued
NDA021606 - ABBVIE
ZEMPLARPARICALCITOLCAPSULE;ORAL4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ZEMPLARPARICALCITOLCAPSULE;ORAL2MCGPrescription
ZEMPLARPARICALCITOLCAPSULE;ORAL1MCGPrescription
NDA021528 - ABBVIE
ACULAR LSKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.4%Prescription
NDA021513 - ABBVIE
ENABLEXDARIFENACIN HYDROBROMIDETABLET, EXTENDED RELEASE;ORALEQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ENABLEXDARIFENACIN HYDROBROMIDETABLET, EXTENDED RELEASE;ORALEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA021487 - ABBVIE
NAMENDAMEMANTINE HYDROCHLORIDETABLET;ORAL10MGPrescription
NAMENDAMEMANTINE HYDROCHLORIDETABLET;ORAL5MGPrescription
NDA021402 - ABBVIE
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
SYNTHROIDLEVOTHYROXINE SODIUMTABLET;ORAL0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumPrescription
NDA021398 - ABBVIE
COMBIGANBRIMONIDINE TARTRATE; TIMOLOL MALEATESOLUTION/DROPS;OPHTHALMIC0.2%;EQ 0.5% BASEPrescription
NDA021365 - ABBVIE
LEXAPROESCITALOPRAM OXALATESOLUTION;ORALEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA021359 - ABBVIE
RECTIVNITROGLYCERINOINTMENT;INTRA-ANAL0.4%Prescription
NDA021323 - ABBVIE
LEXAPROESCITALOPRAM OXALATETABLET;ORALEQ 5MG BASEPrescription
LEXAPROESCITALOPRAM OXALATETABLET;ORALEQ 10MG BASEPrescription
LEXAPROESCITALOPRAM OXALATETABLET;ORALEQ 20MG BASEPrescription
NDA021275 - ABBVIE
LUMIGANBIMATOPROSTSOLUTION/DROPS;OPHTHALMIC0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA021268 - ABBVIE
TEVETEN HCTEPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDETABLET;ORAL600MG;12.5MGDiscontinued
TEVETEN HCTEPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDETABLET;ORAL600MG;25MGDiscontinued
NDA021262 - ABBVIE
ALPHAGAN PBRIMONIDINE TARTRATESOLUTION/DROPS;OPHTHALMIC0.15%Prescription
NDA021252 - ABBVIE
CANASAMESALAMINESUPPOSITORY;RECTAL1GMPrescription
CANASAMESALAMINESUPPOSITORY;RECTAL500MGDiscontinued
NDA021251 - ABBVIE
KALETRALOPINAVIR; RITONAVIRSOLUTION;ORAL80MG/ML;20MG/MLPrescription
NDA021226 - ABBVIE
KALETRALOPINAVIR; RITONAVIRCAPSULE;ORAL133.3MG;33.3MGDiscontinued
NDA021203 - ABBVIE
TRICORFENOFIBRATETABLET;ORAL54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
TRICORFENOFIBRATETABLET;ORAL160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA021168 - ABBVIE
DEPAKOTE ERDIVALPROEX SODIUMTABLET, EXTENDED RELEASE;ORALEQ 250MG VALPROIC ACIDPrescription
DEPAKOTE ERDIVALPROEX SODIUMTABLET, EXTENDED RELEASE;ORALEQ 500MG VALPROIC ACIDPrescription
NDA020945 - ABBVIE
NORVIRRITONAVIRCAPSULE;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020822 - ABBVIE
CELEXACITALOPRAM HYDROBROMIDETABLET;ORALEQ 10MG BASEPrescription
CELEXACITALOPRAM HYDROBROMIDETABLET;ORALEQ 40MG BASEPrescription
CELEXACITALOPRAM HYDROBROMIDETABLET;ORALEQ 60MG BASEDiscontinued
CELEXACITALOPRAM HYDROBROMIDETABLET;ORALEQ 20MG BASEPrescription
NDA020819 - ABBVIE
ZEMPLARPARICALCITOLSOLUTION;INTRAVENOUS0.005MG/ML (0.005MG/ML)Prescription
ZEMPLARPARICALCITOLSOLUTION;INTRAVENOUS0.002MG/ML (0.002MG/ML)Prescription
ZEMPLARPARICALCITOLSOLUTION;INTRAVENOUS0.01MG/2ML (0.005MG/ML)Prescription
NDA020738 - ABBVIE
TEVETENEPROSARTAN MESYLATETABLET;ORALEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
TEVETENEPROSARTAN MESYLATETABLET;ORALEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
TEVETENEPROSARTAN MESYLATETABLET;ORALEQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
BLA020725 - ABBVIE
CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL60,000USP UNITS;12,000USP UNITS;38,000USP UNITSPrescription
CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL120,000USP UNITS;24,000USP UNITS;76,000USP UNITSPrescription
CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL15,000USP UNITS;3,000USP UNITS;9,500USP UNITSPrescription
CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL180,000USP UNITS;36,000USP UNITS;114,000USP UNITSPrescription
CREONPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)CAPSULE, DELAYED RELEASE;ORAL30,000USP UNITS;6,000USP UNITS;19,000USP UNITSPrescription
NDA020716 - ABBVIE
VICOPROFENHYDROCODONE BITARTRATE; IBUPROFENTABLET;ORAL7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020708 - ABBVIE ENDOCRINE INC
LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION11.25MGPrescription
NDA020659 - ABBVIE
NORVIRRITONAVIRSOLUTION;ORAL80MG/MLDiscontinued
NDA020655 - ABBVIE
ALORAESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.05MG/24HRDiscontinued
ALORAESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.075MG/24HRDiscontinued
ALORAESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/24HRDiscontinued
ALORAESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.025MG/24HRDiscontinued
NDA020593 - ABBVIE
DEPACONVALPROATE SODIUMINJECTABLE;INJECTIONEQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020591 - ABBVIE
TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2MG;180MGDiscontinued
TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL4MG;240MGDiscontinued
TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
TARKATRANDOLAPRIL; VERAPAMIL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL2MG;240MGDiscontinued
NDA020551 - ABBVIE
NIMBEXCISATRACURIUM BESYLATEINJECTABLE;INJECTIONEQ 2MG BASE/MLDiscontinued
NIMBEX PRESERVATIVE FREECISATRACURIUM BESYLATEINJECTABLE;INJECTIONEQ 10MG BASE/MLDiscontinued
NIMBEX PRESERVATIVE FREECISATRACURIUM BESYLATEINJECTABLE;INJECTIONEQ 2MG BASE/MLDiscontinued
NDA020528 - ABBVIE
MAVIKTRANDOLAPRILTABLET;ORAL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
MAVIKTRANDOLAPRILTABLET;ORAL2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
MAVIKTRANDOLAPRILTABLET;ORAL4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA020517 - ABBVIE ENDOCRINE INC
LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION30MGPrescription
LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION45MGPrescription
LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION22.5MGPrescription
NDA020489 - ABBVIE
ANDRODERMTESTOSTERONEFILM, EXTENDED RELEASE;TRANSDERMAL2.5MG/24HRDiscontinued
ANDRODERMTESTOSTERONEFILM, EXTENDED RELEASE;TRANSDERMAL2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANDRODERMTESTOSTERONEFILM, EXTENDED RELEASE;TRANSDERMAL4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ANDRODERMTESTOSTERONEFILM, EXTENDED RELEASE;TRANSDERMAL5MG/24HRDiscontinued
NDA020478 - ABBVIE
ULTANESEVOFLURANELIQUID;INHALATION100%Prescription
NDA020381 - ABBVIE
NIASPANNIACINTABLET, EXTENDED RELEASE;ORAL375MGDiscontinued
NIASPANNIACINTABLET, EXTENDED RELEASE;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NIASPANNIACINTABLET, EXTENDED RELEASE;ORAL750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NIASPANNIACINTABLET, EXTENDED RELEASE;ORAL1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NIASPAN TITRATION STARTER PACKNIACINTABLET, EXTENDED RELEASE;ORAL375MG;500MG;750MGDiscontinued
NDA020263 - ABBVIE ENDOCRINE INC
LUPRON DEPOT-PED KITLEUPROLIDE ACETATEPOWDER;INTRAMUSCULAR7.5MGPrescription
LUPRON DEPOT-PED KITLEUPROLIDE ACETATEPOWDER;INTRAMUSCULAR3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
LUPRON DEPOT-PED KITLEUPROLIDE ACETATEPOWDER;INTRAMUSCULAR7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
LUPRON DEPOT-PED KITLEUPROLIDE ACETATEPOWDER;INTRAMUSCULAR11.25MGPrescription
LUPRON DEPOT-PED KITLEUPROLIDE ACETATEPOWDER;INTRAMUSCULAR15MGPrescription
LUPRON DEPOT-PED KITLEUPROLIDE ACETATEPOWDER;INTRAMUSCULAR11.25MGPrescription
LUPRON DEPOT-PED KITLEUPROLIDE ACETATEPOWDER;INTRAMUSCULAR30MGPrescription
LUPRON DEPOT-PED KITLEUPROLIDE ACETATEPOWDER;INTRAMUSCULAR45MGPrescription
NDA020200 - ABBVIE
NALBUPHINE HYDROCHLORIDENALBUPHINE HYDROCHLORIDEINJECTABLE;INJECTION1.5MG/MLDiscontinued
NDA020098 - ABBVIE
MIVACRONMIVACURIUM CHLORIDESOLUTION;INTRAVENOUSEQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
MIVACRONMIVACURIUM CHLORIDESOLUTION;INTRAVENOUSEQ 10MG BASE/5ML (EQ 2MG BASE/ML)Discontinued
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINERMIVACURIUM CHLORIDEINJECTABLE;INJECTIONEQ 50MG BASE/100MLDiscontinued
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINERMIVACURIUM CHLORIDEINJECTABLE;INJECTIONEQ 0.5MG BASE/MLDiscontinued
MIVACRONMIVACURIUM CHLORIDESOLUTION;INTRAVENOUSEQ 20MG BASE/10ML (EQ 2MG BASE/ML)Discontinued
BLA020032 - ABBVIE
SURVANTABERACTANTSUSPENSION;INTRATRACHEAL25MG/MLPrescription
NDA020011 - ABBVIE ENDOCRINE INC
LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION3.75MGPrescription
NDA019946 - ABBVIE
NUROMAXDOXACURIUM CHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/MLDiscontinued
NDA019943 - ABBVIE ENDOCRINE INC
LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE; INJECTION3.75MGPrescription
NDA019732 - ABBVIE ENDOCRINE INC
LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION7.5MGPrescription
NDA019700 - ABBVIE
ACULARKETOROLAC TROMETHAMINESOLUTION/DROPS;OPHTHALMIC0.5%Prescription
NDA019680 - ABBVIE
DEPAKOTEDIVALPROEX SODIUMCAPSULE, DELAYED REL PELLETS;ORALEQ 125MG VALPROIC ACIDPrescription
NDA019304 - ABBVIE
TRICOR (MICRONIZED)FENOFIBRATECAPSULE;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
LIPIDILFENOFIBRATECAPSULE;ORAL100MGDiscontinued
TRICOR (MICRONIZED)FENOFIBRATECAPSULE;ORAL134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
TRICOR (MICRONIZED)FENOFIBRATECAPSULE;ORAL67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA019216 - ABBVIE
FML FORTEFLUOROMETHOLONESUSPENSION/DROPS;OPHTHALMIC0.25%Prescription
NDA019204 - ABBVIE
CARTROLCARTEOLOL HYDROCHLORIDETABLET;ORAL5MGDiscontinued
CARTROLCARTEOLOL HYDROCHLORIDETABLET;ORAL10MGDiscontinued
CARTROLCARTEOLOL HYDROCHLORIDETABLET;ORAL2.5MGDiscontinued
NDA019183 - ABBVIE
CARAFATESUCRALFATESUSPENSION;ORAL1GM/10MLPrescription
NDA019010 - ABBVIE ENDOCRINE INC
LUPRONLEUPROLIDE ACETATESOLUTION;SUBCUTANEOUS14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018874 - ABBVIE
CALCIJEXCALCITRIOLINJECTABLE;INJECTION0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
CALCIJEXCALCITRIOLINJECTABLE;INJECTION0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018723 - ABBVIE
DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 500MG VALPROIC ACIDPrescription
DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 125MG VALPROIC ACIDPrescription
DEPAKOTEDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 250MG VALPROIC ACIDPrescription
NDA018450 - ABBVIE
NITROPRESSSODIUM NITROPRUSSIDEINJECTABLE;INJECTION50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018333 - ABBVIE
CARAFATESUCRALFATETABLET;ORAL1GMPrescription
NDA018279 - ABBVIE
K-TABPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
K-TABPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
K-TABPOTASSIUM CHLORIDETABLET, EXTENDED RELEASE;ORAL20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018117 - ABBVIE
AZMACORTTRIAMCINOLONE ACETONIDEAEROSOL, METERED;INHALATION0.1MG/INHDiscontinued
NDA018082 - ABBVIE
DEPAKENEVALPROIC ACIDSYRUP;ORAL250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA018081 - ABBVIE
DEPAKENEVALPROIC ACIDCAPSULE;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA017100 - ABBVIE
PRED MILDPREDNISOLONE ACETATESUSPENSION/DROPS;OPHTHALMIC0.12%Prescription
NDA017011 - ABBVIE
PRED FORTEPREDNISOLONE ACETATESUSPENSION/DROPS;OPHTHALMIC1%Prescription
NDA016851 - ABBVIE
FMLFLUOROMETHOLONESUSPENSION/DROPS;OPHTHALMIC0.1%Prescription
NDA012524 - ABBVIE
ENDURONMETHYCLOTHIAZIDETABLET;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
ENDURONMETHYCLOTHIAZIDETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA012418 - ABBVIE
AKINETONBIPERIDEN LACTATEINJECTABLE;INJECTION5MG/MLDiscontinued
NDA012302 - ABBVIE
CHOLOXINDEXTROTHYROXINE SODIUMTABLET;ORAL2MGDiscontinued
CHOLOXINDEXTROTHYROXINE SODIUMTABLET;ORAL4MGDiscontinued
CHOLOXINDEXTROTHYROXINE SODIUMTABLET;ORAL1MGDiscontinued
CHOLOXINDEXTROTHYROXINE SODIUMTABLET;ORAL6MGDiscontinued
NDA012148 - ABBVIE
ORETICYL 25DESERPIDINE; HYDROCHLOROTHIAZIDETABLET;ORAL0.125MG;25MGDiscontinued
ORETICYL FORTEDESERPIDINE; HYDROCHLOROTHIAZIDETABLET;ORAL0.25MG;25MGDiscontinued
ORETICYL 50DESERPIDINE; HYDROCHLOROTHIAZIDETABLET;ORAL0.125MG;50MGDiscontinued
NDA012003 - ABBVIE
AKINETONBIPERIDEN HYDROCHLORIDETABLET;ORAL2MGDiscontinued
NDA011971 - ABBVIE
ORETICHYDROCHLOROTHIAZIDETABLET;ORAL25MGDiscontinued
ORETICHYDROCHLOROTHIAZIDETABLET;ORAL50MGDiscontinued
NDA010796 - ABBVIE
HARMONYLDESERPIDINETABLET;ORAL0.1MGDiscontinued
HARMONYLDESERPIDINETABLET;ORAL0.25MGDiscontinued
NDA010599 - ABBVIE
TRALHEXOCYCLIUM METHYLSULFATETABLET;ORAL25MGDiscontinued
NDA010021 - ABBVIE
PLACIDYLETHCHLORVYNOLCAPSULE;ORAL500MGDiscontinued
PLACIDYLETHCHLORVYNOLCAPSULE;ORAL100MGDiscontinued
PLACIDYLETHCHLORVYNOLCAPSULE;ORAL200MGDiscontinued
PLACIDYLETHCHLORVYNOLCAPSULE;ORAL750MGDiscontinued
NDA008370 - ABBVIE
BENTYL PRESERVATIVE FREEDICYCLOMINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLDiscontinued
BENTYLDICYCLOMINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLDiscontinued
NDA008322 - ABBVIE
GEMONILMETHARBITALTABLET;ORAL100MGDiscontinued
NDA007707 - ABBVIE
PHENURONEPHENACEMIDETABLET;ORAL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinued
NDA006905 - ABBVIE
NORISODRINEISOPROTERENOL SULFATEPOWDER;INHALATION25%Discontinued
NORISODRINEISOPROTERENOL SULFATEPOWDER;INHALATION10%Discontinued
NDA006800 - ABBVIE
PARADIONEPARAMETHADIONECAPSULE;ORAL150MGDiscontinued
PARADIONEPARAMETHADIONECAPSULE;ORAL300MGDiscontinued
PARADIONEPARAMETHADIONESOLUTION;ORAL300MG/MLDiscontinued
NDA006044 - ABBVIE
DIASONE SODIUMSULFOXONE SODIUMTABLET, DELAYED RELEASE;ORAL165MGDiscontinued
NDA005932 - ABBVIE
AMINOSOL 5%PROTEIN HYDROLYSATEINJECTABLE;INJECTION5%Discontinued
NDA005856 - ABBVIE
TRIDIONETRIMETHADIONECAPSULE;ORAL300MGDiscontinued
TRIDIONETRIMETHADIONESOLUTION;ORAL200MG/5MLDiscontinued
TRIDIONETRIMETHADIONETABLET;ORAL150MGDiscontinued
NDA005545 - ABBVIE
DICUMAROLDICUMAROLTABLET;ORAL25MGDiscontinued
DICUMAROLDICUMAROLTABLET;ORAL50MGDiscontinued
DICUMAROLDICUMAROLTABLET;ORAL100MGDiscontinued
NDA004125 - ABBVIE
SULFADIAZINESULFADIAZINETABLET;ORAL300MGDiscontinued