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Zydus Lifesciences FDA Approvals

70 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
MUPIROCIN CALCIUMNew drugSep 29, 2026CREAM, TOPICAL
TRETINOINNew drugSep 15, 2026CREAM, TOPICAL
LETROZOLENew drugSep 14, 2026TABLET, ORAL
RIFABUTINNew drugAug 21, 2026CAPSULE, ORAL
INDOCYANINE GREENNew drugAug 3, 2026INJECTABLE, INJECTION
FLUORESCEIN SODIUMNew drugJun 1, 2026INJECTABLE, INTRAVENOUS
AMMONIUM LACTATENew drugMay 15, 2026LOTION, TOPICAL
CEVIMELINE HYDROCHLORIDENew drugMar 11, 2026CAPSULE, ORAL
IVERMECTINNew drugFeb 26, 2026TABLET, ORAL
DAPSONENew drugFeb 26, 2026TABLET, ORAL
METRONIDAZOLENew drugFeb 13, 2026GEL, TOPICAL
AMMONIUM LACTATENew drugFeb 12, 2026CREAM, TOPICAL
SERTRALINE HYDROCHLORIDENew drugJan 29, 2026CAPSULE, ORAL
VERAPAMIL HYDROCHLORIDENew drugNov 24, 2025TABLET, EXTENDED RELEASE, ORAL
DEFLAZACORTNew drugOct 3, 2025SUSPENSION, ORAL
DILTIAZEM HYDROCHLORIDENew drugAug 8, 2025TABLET, ORAL
PRUCALOPRIDE SUCCINATENew drugAug 7, 2025TABLET, ORAL
JAYTHARINew drugApr 8, 2025TABLET, ORAL
APALUTAMIDENew drugMar 17, 2025TABLET, ORAL
METHENAMINE HIPPURATENew drugMar 10, 2025TABLET, ORAL
KETOCONAZOLENew drugMar 7, 2025SHAMPOO, TOPICAL
IBUPROFEN AND FAMOTIDINENew drugFeb 20, 2025TABLET, ORAL
LIDOCAINE AND PRILOCAINENew drugDec 17, 2024CREAM, TOPICAL
FLUDROCORTISONE ACETATENew drugOct 16, 2024TABLET, ORAL
VALBENAZINE TOSYLATENew drugAug 7, 2024CAPSULE, ORAL
VALSARTANNew drugJul 22, 2024TABLET, ORAL
ZITUVIMET XRNew drugJul 18, 2024TABLET, EXTENDED RELEASE, ORAL
PALBOCICLIBNew drugJun 5, 2024TABLET, ORAL
THEOPHYLLINENew drugMay 21, 2024TABLET, EXTENDED RELEASE, ORAL
DEXAMETHASONENew drugMay 9, 2024TABLET, ORAL
DAPSONENew drugMay 8, 2024GEL, TOPICAL
TRETINOINNew drugApr 25, 2024CREAM, TOPICAL
FINASTERIDE AND TADALAFILNew drugMar 15, 2024CAPSULE, ORAL
DEXAMETHASONENew drugFeb 7, 2024TABLET, ORAL
DEXAMETHASONENew drugFeb 7, 2024TABLET, ORAL
CYCLOPHOSPHAMIDENew drugDec 13, 2023CAPSULE, ORAL
DARUNAVIRNew drugDec 13, 2023TABLET, ORAL
METHYLENE BLUENew drugDec 5, 2023SOLUTION, INTRAVENOUS
ZITUVIMETNew drugNov 3, 2023TABLET, ORAL
ZITUVIONew drugOct 18, 2023TABLET, ORAL
CLINDAMYCIN PHOSPHATENew drugSep 19, 2023GEL, TOPICAL
DOXEPIN HYDROCHLORIDENew drugAug 16, 2023TABLET, ORAL
INDOMETHACINNew drugAug 2, 2023SUPPOSITORY, RECTAL
BALSALAZIDE DISODIUMNew drugJun 8, 2023CAPSULE, ORAL
SUCRALFATENew drugMay 3, 2023TABLET, ORAL
METRONIDAZOLENew drugApr 21, 2023CREAM, TOPICAL
ICOSAPENT ETHYLNew drugApr 20, 2023CAPSULE, ORAL
TAVABOROLENew drugApr 10, 2023SOLUTION, TOPICAL
ACETAZOLAMIDENew drugApr 4, 2023TABLET, ORAL
LOPERAMIDE HYDROCHLORIDENew drugMar 23, 2023CAPSULE, ORAL
DOXEPIN HYDROCHLORIDENew drugMar 23, 2023CAPSULE, ORAL
DOXEPIN HYDROCHLORIDENew drugMar 21, 2023CAPSULE, ORAL
ERYTHROMYCINNew drugMar 7, 2023TABLET, ORAL
VIGABATRINNew drugMar 2, 2023FOR SOLUTION, ORAL
ACYCLOVIRNew drugFeb 28, 2023CREAM, TOPICAL
FEBUXOSTATNew drugJan 9, 2023TABLET, ORAL
SELEXIPAGNew drugDec 21, 2022TABLET, ORAL
KETOROLAC TROMETHAMINENew drugOct 21, 2022TABLET, ORAL
SILDENAFIL CITRATENew drugSep 29, 2022FOR SUSPENSION, ORAL
PROCHLORPERAZINE MALEATENew drugAug 8, 2022TABLET, ORAL
IVERMECTINNew drugAug 2, 2022CREAM, TOPICAL
BISOPROLOL FUMARATENew drugJul 25, 2022TABLET, ORAL
EFINACONAZOLENew drugJul 15, 2022SOLUTION, TOPICAL
VIGABATRINNew drugJan 19, 2022TABLET, ORAL
FLUPHENAZINE HYDROCHLORIDENew drugMay 27, 2021TABLET, ORAL
PROPAFENONE HYDROCHLORIDENew drugApr 21, 2021CAPSULE, EXTENDED RELEASE, ORAL
MACITENTANNew drugApr 6, 2021TABLET, ORAL
IBRUTINIBNew drugMar 31, 2021CAPSULE, ORAL
NORTRIPTYLINE HYDROCHLORIDENew drugFeb 24, 2021CAPSULE, ORAL
LIOTHYRONINE SODIUMNew drugJan 22, 2021TABLET, ORAL

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