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Aurobindo Pharma Ltd FDA Approvals

121 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
PERAMPANELNew drugOct 2, 2026TABLET, ORAL
METRONIDAZOLENew drugSep 25, 2026GEL, VAGINAL
CYCLOSPORINENew drugSep 17, 2026CAPSULE, ORAL
ISOTRETINOINNew drugSep 10, 2026CAPSULE, ORAL
SACUBITRIL AND VALSARTANNew drugSep 2, 2026TABLET, ORAL
TRIAMCINOLONE ACETONIDENew drugAug 11, 2026SPRAY, METERED, NASAL
ADAPALENE AND BENZOYL PEROXIDENew drugJul 22, 2026GEL, TOPICAL
BUPROPION HYDROCHLORIDENew drugJul 21, 2026TABLET, EXTENDED RELEASE, ORAL
ETODOLACNew drugJul 15, 2026TABLET, ORAL
ICOSAPENT ETHYLNew drugJun 24, 2026CAPSULE, ORAL
TOFACITINIB CITRATENew drugJun 3, 2026TABLET, ORAL
CANAGLIFLOZINNew drugApr 20, 2026TABLET, ORAL
DEXTROMETHORPHAN POLISTIREXNew drugApr 15, 2026SUSPENSION, EXTENDED RELEASE, ORAL
CEFIXIMENew drugMar 23, 2026CAPSULE, ORAL
CLINDAMYCIN PHOSPHATENew drugMar 18, 2026GEL, TOPICAL
CITALOPRAM HYDROBROMIDENew drugMar 13, 2026CAPSULE, ORAL
SIPONIMODNew drugMar 6, 2026TABLET, ORAL
BETAMETHASONE DIPROPIONATENew drugJan 26, 2026CREAM, TOPICAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDENew drugJan 21, 2026TABLET, ORAL
PSEUDOEPHEDRINE HYDROCHLORIDENew drugDec 29, 2025TABLET, EXTENDED RELEASE, ORAL
CARIPRAZINE HYDROCHLORIDENew drugDec 16, 2025CAPSULE, ORAL
FOSFOMYCIN TROMETHAMINENew drugNov 14, 2025FOR SOLUTION, ORAL
LINAGLIPTINNew drugNov 3, 2025TABLET, ORAL
PROCHLORPERAZINE MALEATENew drugSep 8, 2025TABLET, ORAL
LIDOCAINE HYDROCHLORIDENew drugJul 29, 2025SOLUTION, ORAL
FUROSEMIDENew drugJul 17, 2025TABLET, ORAL
FAMOTIDINENew drugJul 9, 2025FOR SUSPENSION, ORAL
METRONIDAZOLENew drugJul 9, 2025CREAM, TOPICAL
IBUPROFEN AND FAMOTIDINENew drugJun 30, 2025TABLET, ORAL
ACETAZOLAMIDENew drugMay 30, 2025TABLET, ORAL
OXCARBAZEPINENew drugApr 30, 2025TABLET, EXTENDED RELEASE, ORAL
CHLORPROMAZINE HYDROCHLORIDENew drugApr 25, 2025TABLET, ORAL
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDENew drugApr 17, 2025TABLET, EXTENDED RELEASE, ORAL
ESOMEPRAZOLE MAGNESIUMNew drugApr 15, 2025FOR SUSPENSION, DELAYED RELEASE, ORAL
ESOMEPRAZOLE MAGNESIUMNew drugApr 15, 2025FOR SUSPENSION, DELAYED RELEASE, ORAL
ALLOPURINOLNew drugApr 14, 2025TABLET, ORAL
RIVAROXABANNew drugApr 10, 2025TABLET, ORAL
DAPSONENew drugApr 4, 2025GEL, TOPICAL
PANTOPRAZOLE SODIUMNew drugMar 31, 2025FOR SUSPENSION, DELAYED RELEASE, ORAL
TRETINOINNew drugFeb 27, 2025GEL, TOPICAL
TRETINOINNew drugJan 13, 2025GEL, TOPICAL
GLYCOPYRROLATENew drugDec 31, 2024SOLUTION, ORAL
DEUTETRABENAZINENew drugDec 26, 2024TABLET, ORAL
CIMETIDINENew drugNov 12, 2024TABLET, ORAL
METRONIDAZOLENew drugOct 15, 2024GEL, TOPICAL
CEPHALEXINNew drugSep 27, 2024TABLET, ORAL
MYCOPHENOLATE MOFETILNew drugSep 26, 2024FOR SUSPENSION, ORAL
DOXEPIN HYDROCHLORIDENew drugJul 25, 2024TABLET, ORAL
BARICITINIBNew drugJul 22, 2024TABLET, ORAL
LIDOCAINENew drugJun 18, 2024OINTMENT, TOPICAL
TOFACITINIB CITRATENew drugJun 3, 2024TABLET, EXTENDED RELEASE, ORAL
FLUTICASONE PROPIONATENew drugMay 10, 2024SPRAY, METERED, NASAL
OSELTAMIVIR PHOSPHATENew drugMay 10, 2024FOR SUSPENSION, ORAL
COLCHICINENew drugApr 29, 2024CAPSULE, ORAL
HALOPERIDOLNew drugApr 19, 2024TABLET, ORAL
BETAMETHASONE DIPROPIONATENew drugApr 10, 2024OINTMENT, AUGMENTED, TOPICAL
IBUPROFENNew drugApr 8, 2024SUSPENSION/DROPS, ORAL
ACETAMINOPHEN AND IBUPROFENNew drugMar 26, 2024TABLET, ORAL
DOCOSANOLNew drugMar 1, 2024CREAM, TOPICAL
FINGOLIMOD HYDROCHLORIDENew drugFeb 28, 2024CAPSULE, ORAL
MYCOPHENOLATE SODIUMNew drugFeb 27, 2024TABLET, DELAYED RELEASE, ORAL
ATORVASTATIN CALCIUMNew drugFeb 13, 2024TABLET, ORAL
DEFLAZACORTNew drugFeb 9, 2024TABLET, ORAL
LACOSAMIDENew drugJan 24, 2024SOLUTION, ORAL
MYCOPHENOLATE MOFETILNew drugJan 5, 2024CAPSULE, ORAL
DIAZEPAMNew drugDec 14, 2023TABLET, ORAL
DARUNAVIRNew drugNov 28, 2023TABLET, ORAL
BREXPIPRAZOLENew drugNov 2, 2023TABLET, ORAL
FEBUXOSTATNew drugOct 25, 2023TABLET, ORAL
DEFERASIROXNew drugOct 16, 2023TABLET, ORAL
TOPIRAMATENew drugSep 27, 2023CAPSULE, ORAL
IBUPROFENNew drugSep 14, 2023CAPSULE, ORAL
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDENew drugSep 14, 2023CAPSULE, ORAL
LOPERAMIDE HYDROCHLORIDENew drugSep 5, 2023CAPSULE, ORAL
FLUPHENAZINE HYDROCHLORIDENew drugAug 18, 2023TABLET, ORAL
APREMILASTNew drugJul 19, 2023TABLET, ORAL
HYDROCORTISONENew drugJul 17, 2023TABLET, ORAL
ERTUGLIFLOZINNew drugJul 13, 2023TABLET, ORAL
ESOMEPRAZOLE MAGNESIUMNew drugJul 12, 2023TABLET, DELAYED RELEASE, ORAL
SEVELAMER HYDROCHLORIDENew drugJul 11, 2023TABLET, ORAL
RAMELTEONNew drugJul 10, 2023TABLET, ORAL
ETYQANew drugJun 30, 2023TABLET, ORAL
APIXABANNew drugMay 26, 2023TABLET, ORAL
FEXOFENADINE HYDROCHLORIDENew drugMay 23, 2023SUSPENSION, ORAL
OMEPRAZOLE MAGNESIUMNew drugApr 28, 2023CAPSULE, DELAYED RELEASE, ORAL
MACITENTANNew drugApr 18, 2023TABLET, ORAL
ROFLUMILASTNew drugApr 17, 2023TABLET, ORAL
PRAZOSIN HYDROCHLORIDENew drugMar 31, 2023CAPSULE, ORAL
MESALAMINENew drugMar 31, 2023CAPSULE, EXTENDED RELEASE, ORAL
LANSOPRAZOLENew drugMar 28, 2023TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE, ORAL
PREDNISOLONENew drugMar 17, 2023TABLET, ORAL
EMTRICITABINENew drugMar 15, 2023CAPSULE, ORAL
LURASIDONE HYDROCHLORIDENew drugMar 10, 2023TABLET, ORAL
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDENew drugMar 10, 2023TABLET, ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENew drugMar 9, 2023TABLET, ORAL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDENew drugMar 8, 2023TABLET, EXTENDED RELEASE, ORAL
PROPAFENONE HYDROCHLORIDENew drugFeb 21, 2023CAPSULE, EXTENDED RELEASE, ORAL
LEVOMILNACIPRAN HYDROCHLORIDENew drugJan 6, 2023CAPSULE, EXTENDED RELEASE, ORAL
BRIVARACETAMNew drugJan 6, 2023TABLET, ORAL
LACOSAMIDENew drugJan 5, 2023TABLET, ORAL
SILDENAFIL CITRATENew drugDec 23, 2022FOR SUSPENSION, ORAL
CARBIDOPA AND LEVODOPANew drugNov 28, 2022TABLET, ORAL
URSODIOLNew drugNov 28, 2022CAPSULE, ORAL
PYRIMETHAMINENew drugOct 25, 2022TABLET, ORAL
NICOTINE POLACRILEXNew drugMay 13, 2022TROCHE/LOZENGE, ORAL
VIGABATRINNew drugMay 10, 2022TABLET, ORAL
PREDNISONENew drugMar 28, 2022TABLET, ORAL
CLOBAZAMNew drugMar 24, 2022SUSPENSION, ORAL
DIGOXINNew drugFeb 8, 2022TABLET, ORAL
ACETAMINOPHEN, ASPIRIN AND CAFFEINENew drugFeb 2, 2022TABLET, ORAL
COLCHICINENew drugJan 6, 2022TABLET, ORAL
NEBIVOLOL HYDROCHLORIDENew drugDec 17, 2021TABLET, ORAL
PREDNISONENew drugNov 16, 2021TABLET, ORAL
DICLOFENAC POTASSIUMNew drugOct 19, 2021CAPSULE, ORAL
VIGABATRINNew drugSep 29, 2021FOR SOLUTION, ORAL
FENOFIBRATE (MICRONIZED)New drugSep 20, 2021CAPSULE, ORAL
MEMANTINE HYDROCHLORIDENew drugAug 9, 2021CAPSULE, EXTENDED RELEASE, ORAL
BACLOFENNew drugJul 13, 2021TABLET, ORAL
POTASSIUM CHLORIDENew drugMar 31, 2021TABLET, EXTENDED RELEASE, ORAL
EFINACONAZOLENew drugMar 29, 2021SOLUTION, TOPICAL
DROXIDOPANew drugFeb 18, 2021CAPSULE, ORAL

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