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Zydus Pharms FDA Approvals

86 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
MEXILETINE HYDROCHLORIDENew drugSep 23, 2026CAPSULE, ORAL
EPINEPHRINENew drugSep 14, 2026SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
ASCORBIC ACIDNew drugAug 20, 2026SOLUTION, INTRAVENOUS
EDARAVONENew drugJul 22, 2026SOLUTION, INTRAVENOUS
FLUVOXAMINE MALEATENew drugJul 21, 2026CAPSULE, EXTENDED RELEASE, ORAL
SELENIOUS ACIDNew drugJun 30, 2026SOLUTION, INTRAVENOUS
HYDROCORTISONE SODIUM SUCCINATENew drugMay 7, 2026INJECTABLE, INJECTION
DAPAGLIFLOZINNew drugApr 6, 2026TABLET, ORAL
CALCITONIN-SALMONNew drugMar 4, 2026INJECTABLE, INJECTION
BOSENTANNew drugFeb 17, 2026TABLET, FOR SUSPENSION, ORAL
ELTROMBOPAG OLAMINENew drugJan 14, 2026TABLET, ORAL
LEUPROLIDE ACETATENew drugNov 13, 2025SOLUTION, SUBCUTANEOUS
CELECOXIBNew drugJul 14, 2025CAPSULE, ORAL
ISOTRETINOINNew drugMay 22, 2025CAPSULE, ORAL
NIACINNew drugApr 28, 2025TABLET, EXTENDED RELEASE, ORAL
ELUXADOLINENew drugMar 14, 2025TABLET, ORAL
DASATINIBNew drugMar 3, 2025TABLET, ORAL
PALIPERIDONENew drugOct 8, 2024TABLET, EXTENDED RELEASE, ORAL
ENZALUTAMIDENew drugSep 26, 2024CAPSULE, ORAL
SCOPOLAMINENew drugAug 29, 2024SYSTEM, TRANSDERMAL
SACUBITRIL AND VALSARTANNew drugJul 9, 2024TABLET, ORAL
CHLORPROMAZINE HYDROCHLORIDENew drugMar 13, 2024INJECTABLE, INJECTION
ISOSORBIDE MONONITRATENew drugFeb 15, 2024TABLET, EXTENDED RELEASE, ORAL
GABAPENTINNew drugJan 24, 2024TABLET, ORAL
LACOSAMIDENew drugDec 15, 2023TABLET, ORAL
IVABRADINE HYDROCHLORIDENew drugNov 29, 2023TABLET, ORAL
SUGAMMADEX SODIUMNew drugOct 4, 2023SOLUTION, INTRAVENOUS
ETHINYL ESTRADIOL AND NORELGESTROMINNew drugSep 14, 2023FILM, EXTENDED RELEASE, TRANSDERMAL
ERYTHROMYCINNew drugAug 31, 2023TABLET, ORAL
ISOTRETINOINNew drugAug 29, 2023CAPSULE, ORAL
ZINC SULFATENew drugAug 22, 2023SOLUTION, INTRAVENOUS
PLERIXAFORNew drugJul 26, 2023SOLUTION, SUBCUTANEOUS
DICLOFENAC SODIUM AND MISOPROSTOLNew drugJun 12, 2023TABLET, DELAYED RELEASE, ORAL
ESOMEPRAZOLE MAGNESIUMNew drugJun 7, 2023FOR SUSPENSION, DELAYED RELEASE, ORAL
TADALAFILNew drugJun 6, 2023TABLET, ORAL
EPHEDRINE SULFATENew drugMay 16, 2023SOLUTION, INTRAVENOUS
METOPROLOL TARTRATENew drugApr 19, 2023TABLET, ORAL
ESTRADIOLNew drugApr 17, 2023SYSTEM, TRANSDERMAL
ISOPROTERENOL HYDROCHLORIDENew drugApr 14, 2023INJECTABLE, INJECTION
AZITHROMYCINNew drugApr 11, 2023TABLET, ORAL
AZITHROMYCINNew drugApr 7, 2023TABLET, ORAL
CARBIDOPA AND LEVODOPANew drugApr 4, 2023TABLET, ORAL
LINAGLIPTINNew drugMar 30, 2023TABLET, ORAL
LINAGLIPTIN AND METFORMIN HYDROCHLORIDENew drugMar 30, 2023TABLET, ORAL
ESTRADIOLNew drugMar 29, 2023FILM, EXTENDED RELEASE, TRANSDERMAL
LEVOTHYROXINE SODIUMNew drugMar 24, 2023POWDER, INTRAVENOUS
LUBIPROSTONENew drugMar 23, 2023CAPSULE, ORAL
TOFACITINIB CITRATENew drugMar 14, 2023TABLET, ORAL
OLANZAPINENew drugMar 9, 2023TABLET, ORALLY DISINTEGRATING, ORAL
APIXABANNew drugFeb 27, 2023TABLET, ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENew drugFeb 24, 2023TABLET, ORAL
PITAVASTATIN CALCIUMNew drugFeb 22, 2023TABLET, ORAL
TOPIRAMATENew drugFeb 9, 2023CAPSULE, EXTENDED RELEASE, ORAL
FENTANYL-100New drugJan 24, 2023FILM, EXTENDED RELEASE, TRANSDERMAL
BREXPIPRAZOLENew drugJan 10, 2023TABLET, ORAL
TRIAZOLAMNew drugDec 28, 2022TABLET, ORAL
PREGABALINNew drugDec 9, 2022CAPSULE, ORAL
SILODOSINNew drugDec 8, 2022CAPSULE, ORAL
ESTRADIOLNew drugDec 1, 2022SYSTEM, TRANSDERMAL
FAMOTIDINENew drugNov 22, 2022INJECTABLE, INJECTION
ACETAMINOPHENNew drugOct 25, 2022SOLUTION, INTRAVENOUS
MICAFUNGIN SODIUMNew drugOct 24, 2022INJECTABLE, INTRAVENOUS
BRIVARACETAMNew drugOct 3, 2022TABLET, ORAL
MIRABEGRONNew drugSep 29, 2022TABLET, EXTENDED RELEASE, ORAL
LENALIDOMIDENew drugSep 12, 2022CAPSULE, ORAL
VENLAFAXINE HYDROCHLORIDENew drugAug 30, 2022TABLET, EXTENDED RELEASE, ORAL
PREGABALINNew drugAug 26, 2022TABLET, EXTENDED RELEASE, ORAL
EMPAGLIFLOZINNew drugAug 3, 2022TABLET, ORAL
NOREPINEPHRINE BITARTRATENew drugJul 19, 2022INJECTABLE, INJECTION
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENew drugJul 7, 2022TABLET, ORAL
LACOSAMIDENew drugJun 29, 2022SOLUTION, INTRAVENOUS
ADAPALENE AND BENZOYL PEROXIDENew drugJun 3, 2022GEL, TOPICAL
FAMOTIDINENew drugJun 3, 2022TABLET, ORAL
PEMETREXED DISODIUMNew drugMay 25, 2022POWDER, INTRAVENOUS
BORTEZOMIBNew drugMay 2, 2022INJECTABLE, INTRAVENOUS, SUBCUTANEOUS
CYANOCOBALAMINNew drugApr 15, 2022INJECTABLE, INJECTION
COLESTIPOL HYDROCHLORIDENew drugMar 10, 2022TABLET, ORAL
NITROGLYCERINNew drugMar 8, 2022TABLET, SUBLINGUAL
ROFLUMILASTNew drugFeb 10, 2022TABLET, ORAL
DECITABINENew drugNov 19, 2021INJECTABLE, INTRAVENOUS
NELARABINENew drugNov 17, 2021INJECTABLE, INTRAVENOUS
GLYCOPYRROLATENew drugNov 9, 2021INJECTABLE, INJECTION
TOFACITINIB CITRATENew drugAug 19, 2021TABLET, EXTENDED RELEASE, ORAL
MESALAMINENew drugAug 12, 2021CAPSULE, EXTENDED RELEASE, ORAL
FULVESTRANTNew drugJul 29, 2021SOLUTION, INTRAMUSCULAR
DROXIDOPANew drugFeb 18, 2021CAPSULE, ORAL

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