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Lupin FDA Approvals

79 new drug approvals and 0 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
PHYTONADIONENew drugSep 30, 2026INJECTABLE, INJECTION
MODAFINILNew drugSep 3, 2026TABLET, ORAL
PITOLISANT HYDROCHLORIDENew drugAug 14, 2026TABLET, ORAL
SODIUM ZIRCONIUM CYCLOSILICATENew drugAug 7, 2026FOR SUSPENSION, ORAL
SUGAMMADEX SODIUMNew drugJul 28, 2026SOLUTION, INTRAVENOUS
DIAZEPAMNew drugJul 27, 2026INJECTABLE, INJECTION
SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDENew drugMay 28, 2026TABLET, ORAL
FAMOTIDINENew drugMay 12, 2026INJECTABLE, INJECTION
GLYCEROL PHENYLBUTYRATENew drugApr 30, 2026LIQUID, ORAL
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENew drugApr 6, 2026TABLET, EXTENDED RELEASE, ORAL
DAPAGLIFLOZINNew drugApr 6, 2026TABLET, ORAL
BRIVARACETAMNew drugFeb 23, 2026SOLUTION, ORAL
RIVAROXABANNew drugSep 25, 2025FOR SUSPENSION, ORAL
LENALIDOMIDENew drugSep 16, 2025CAPSULE, ORAL
DASATINIBNew drugAug 25, 2025TABLET, ORAL
GLUCAGONNew drugJul 22, 2025INJECTABLE, INJECTION
LIRAGLUTIDENew drugJul 22, 2025SOLUTION, SUBCUTANEOUS
LOTEPREDNOL ETABONATENew drugJun 30, 2025GEL, OPHTHALMIC
PRUCALOPRIDE SUCCINATENew drugJun 24, 2025TABLET, ORAL
RALTEGRAVIR POTASSIUMNew drugMay 6, 2025TABLET, ORAL
TOLVAPTANNew drugApr 23, 2025TABLET, ORAL
RIVAROXABANNew drugMar 3, 2025TABLET, ORAL
IPRATROPIUM BROMIDENew drugFeb 7, 2025SPRAY, METERED, NASAL
IPRATROPIUM BROMIDENew drugJan 27, 2025SPRAY, METERED, NASAL
SACUBITRIL AND VALSARTANNew drugJan 8, 2025TABLET, ORAL
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATENew drugDec 13, 2024TABLET, ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATENew drugNov 7, 2024CAPSULE, EXTENDED RELEASE, ORAL
BUMETANIDENew drugSep 17, 2024INJECTABLE, INJECTION
BRIMONIDINE TARTRATENew drugAug 26, 2024SOLUTION/DROPS, OPHTHALMIC
PREDNISOLONE ACETATENew drugAug 2, 2024SUSPENSION/DROPS, OPHTHALMIC
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)New drugJul 16, 2024INJECTABLE, LIPOSOMAL, INJECTION
TOPIRAMATENew drugJul 11, 2024CAPSULE, EXTENDED RELEASE, ORAL
MIDOSTAURINNew drugMay 10, 2024CAPSULE, ORAL
TRAVOPROSTNew drugMay 3, 2024SOLUTION/DROPS, OPHTHALMIC
LOTEPREDNOL ETABONATENew drugApr 24, 2024SUSPENSION/DROPS, OPHTHALMIC
DOXYCYCLINENew drugApr 8, 2024CAPSULE, ORAL
VALBENAZINE TOSYLATENew drugApr 5, 2024CAPSULE, ORAL
ESLICARBAZEPINE ACETATENew drugMar 27, 2024TABLET, ORAL
ARIPIPRAZOLENew drugMar 18, 2024TABLET, ORAL
DOXYCYCLINE HYCLATENew drugMar 14, 2024INJECTABLE, INJECTION
MINZOYANew drugFeb 15, 2024TABLET, ORAL
BROMFENAC SODIUMNew drugFeb 2, 2024SOLUTION/DROPS, OPHTHALMIC
DRONEDARONE HYDROCHLORIDENew drugJan 31, 2024TABLET, ORAL
FEBUXOSTATNew drugJan 17, 2024TABLET, ORAL
PROPRANOLOL HYDROCHLORIDENew drugJan 12, 2024CAPSULE, EXTENDED RELEASE, ORAL
LOTEPREDNOL ETABONATENew drugDec 26, 2023SUSPENSION/DROPS, OPHTHALMIC
ALLOPURINOLNew drugDec 14, 2023TABLET, ORAL
VARENICLINE TARTRATENew drugDec 4, 2023TABLET, ORAL
BROMFENAC SODIUMNew drugNov 22, 2023SOLUTION/DROPS, OPHTHALMIC
PITAVASTATIN CALCIUMNew drugNov 20, 2023TABLET, ORAL
GANIRELIX ACETATENew drugNov 16, 2023INJECTABLE, INJECTION
FLUCONAZOLENew drugOct 20, 2023TABLET, ORAL
METOPROLOL SUCCINATENew drugAug 15, 2023TABLET, EXTENDED RELEASE, ORAL
BROMFENAC SODIUMNew drugAug 15, 2023SOLUTION/DROPS, OPHTHALMIC
DOXYCYCLINE HYCLATENew drugAug 11, 2023TABLET, DELAYED RELEASE, ORAL
TURQOZNew drugJul 31, 2023TABLET, ORAL-28
CHLORPROMAZINE HYDROCHLORIDENew drugJul 13, 2023TABLET, ORAL
CYANOCOBALAMINNew drugJun 30, 2023SPRAY, METERED, NASAL
TIOTROPIUM BROMIDENew drugJun 20, 2023POWDER, INHALATION
OBETICHOLIC ACIDNew drugMay 30, 2023TABLET, ORAL
TENOFOVIR ALAFENAMIDENew drugMar 30, 2023TABLET, ORAL
BREXPIPRAZOLENew drugMar 18, 2023TABLET, ORAL
GLYCOPYRROLATENew drugFeb 7, 2023INJECTABLE, INJECTION
PRASUGRELNew drugJan 9, 2023TABLET, ORAL
BRIVARACETAMNew drugDec 20, 2022TABLET, ORAL
DARUNAVIRNew drugSep 29, 2022TABLET, ORAL
MIRABEGRONNew drugSep 28, 2022TABLET, EXTENDED RELEASE, ORAL
FORMOTEROL FUMARATENew drugAug 22, 2022SOLUTION, INHALATION
RUFINAMIDENew drugAug 17, 2022TABLET, ORAL
AZILSARTAN MEDOXOMILNew drugJul 20, 2022TABLET, ORAL
PALIPERIDONENew drugJun 29, 2022TABLET, EXTENDED RELEASE, ORAL
ILOPERIDONENew drugMay 5, 2022TABLET, ORAL
SILDENAFIL CITRATENew drugMar 23, 2022FOR SUSPENSION, ORAL
EFINACONAZOLENew drugMar 2, 2022SOLUTION, TOPICAL
ARFORMOTEROL TARTRATENew drugFeb 7, 2022SOLUTION, INHALATION
SEVELAMER CARBONATENew drugDec 23, 2021FOR SUSPENSION, ORAL
SEVELAMER HYDROCHLORIDENew drugJun 16, 2021TABLET, ORAL
TAVABOROLENew drugFeb 8, 2021SOLUTION, TOPICAL
SULFAMETHOXAZOLE AND TRIMETHOPRIMNew drugJan 5, 2021SUSPENSION, ORAL

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