← Every applicant
Alkem Labs Ltd FDA Approvals
68 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 |
|---|
| SOLRIAMFETOL HYDROCHLORIDENew drugJun 17, 2026TABLET, ORAL |
| TOLVAPTANNew drugApr 21, 2026TABLET, ORAL |
| DAPAGLIFLOZINNew drugApr 6, 2026TABLET, ORAL |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENew drugApr 6, 2026TABLET, EXTENDED RELEASE, ORAL |
| BRIVARACETAMNew drugFeb 23, 2026SOLUTION, ORAL |
| MIRABEGRONNew drugJan 20, 2026FOR SUSPENSION, EXTENDED RELEASE, ORAL |
| TICAGRELORNew drugOct 28, 2025TABLET, ORAL |
| LIDOCAINENew drugOct 6, 2025PATCH, TOPICAL |
| RIVAROXABANNew drugJun 26, 2025FOR SUSPENSION, ORAL |
| PRUCALOPRIDE SUCCINATENew drugJun 24, 2025TABLET, ORAL |
| LANTHANUM CARBONATENew drugMar 13, 2025TABLET, CHEWABLE, ORAL |
| NIMODIPINENew drugJan 22, 2025SOLUTION, ORAL |
| AZILSARTAN MEDOXOMIL AND CHLORTHALIDONENew drugJan 21, 2025TABLET, ORAL |
| CARBAMAZEPINENew drugJan 14, 2025TABLET, EXTENDED RELEASE, ORAL |
| TOPIRAMATENew drugOct 31, 2024SOLUTION, ORAL |
| CEPHALEXINNew drugSep 27, 2024TABLET, ORAL |
| SACUBITRIL AND VALSARTANNew drugSep 16, 2024TABLET, ORAL |
| RILUZOLENew drugAug 22, 2024SUSPENSION, ORAL |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENew drugJul 11, 2024TABLET, ORAL |
| TOPIRAMATENew drugJun 13, 2024CAPSULE, ORAL |
| CEFPROZILNew drugApr 9, 2024TABLET, ORAL |
| OXCARBAZEPINENew drugMar 18, 2024SUSPENSION, ORAL |
| MIRABEGRONNew drugFeb 12, 2024TABLET, EXTENDED RELEASE, ORAL |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATENew drugDec 29, 2023SOLUTION, ORAL |
| CLOPIDOGREL BISULFATENew drugDec 8, 2023TABLET, ORAL |
| BREXPIPRAZOLENew drugNov 28, 2023TABLET, ORAL |
| ESLICARBAZEPINE ACETATENew drugOct 6, 2023TABLET, ORAL |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATENew drugOct 6, 2023TABLET, ORAL |
| LISDEXAMFETAMINE DIMESYLATENew drugAug 25, 2023CAPSULE, ORAL |
| TEMAZEPAMNew drugAug 24, 2023CAPSULE, ORAL |
| VARENICLINE TARTRATENew drugAug 23, 2023TABLET, ORAL |
| TOPIRAMATENew drugJun 20, 2023CAPSULE, EXTENDED RELEASE, ORAL |
| METHYLPHENIDATE HYDROCHLORIDENew drugMay 23, 2023TABLET, EXTENDED RELEASE, ORAL |
| FAMOTIDINENew drugMay 15, 2023FOR SUSPENSION, ORAL |
| FAMOTIDINENew drugApr 24, 2023TABLET, ORAL |
| TICAGRELORNew drugApr 21, 2023TABLET, ORAL |
| ROFLUMILASTNew drugApr 18, 2023TABLET, ORAL |
| LURASIDONE HYDROCHLORIDENew drugDec 13, 2022TABLET, ORAL |
| VANCOMYCIN HYDROCHLORIDENew drugNov 14, 2022FOR SOLUTION, ORAL |
| DICLOFENAC POTASSIUMNew drugJul 20, 2022FOR SOLUTION, ORAL |
| ERYTHROMYCINNew drugJul 13, 2022TABLET, ORAL |
| LEVETIRACETAMNew drugMay 27, 2022TABLET, ORAL |
| LACOSAMIDENew drugMay 19, 2022SOLUTION, ORAL |
| CEFPODOXIME PROXETILNew drugMay 18, 2022TABLET, ORAL |
| LACOSAMIDENew drugMar 31, 2022TABLET, ORAL |
| ENALAPRIL MALEATENew drugMar 30, 2022SOLUTION, ORAL |
| NIFEDIPINENew drugMar 29, 2022TABLET, EXTENDED RELEASE, ORAL |
| FEBUXOSTATNew drugDec 7, 2021TABLET, ORAL |
| EVEROLIMUSNew drugNov 26, 2021TABLET, ORAL |
| FOSFOMYCIN TROMETHAMINENew drugOct 21, 2021FOR SOLUTION, ORAL |
| CHOLESTYRAMINENew drugOct 19, 2021POWDER, ORAL |
| CHOLESTYRAMINE LIGHTNew drugOct 19, 2021POWDER, ORAL |
| MYCOPHENOLATE SODIUMNew drugSep 23, 2021TABLET, DELAYED RELEASE, ORAL |
| APREMILASTNew drugSep 21, 2021TABLET, ORAL |
| IBUPROFENNew drugSep 13, 2021TABLET, ORAL |
| IBUPROFEN AND FAMOTIDINENew drugAug 3, 2021TABLET, ORAL |
| MESALAMINENew drugJul 15, 2021CAPSULE, EXTENDED RELEASE, ORAL |
| BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDENew drugJun 15, 2021TABLET, SUBLINGUAL |
| VENLAFAXINE HYDROCHLORIDENew drugJun 10, 2021TABLET, EXTENDED RELEASE, ORAL |
| CLOBAZAMNew drugMay 6, 2021SUSPENSION, ORAL |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDENew drugApr 26, 2021CAPSULE, ORAL |
| TOBRAMYCINNew drugApr 1, 2021SOLUTION, INHALATION |
| SIROLIMUSNew drugMar 12, 2021TABLET, ORAL |
| RUFINAMIDENew drugFeb 23, 2021SUSPENSION, ORAL |
| CEFIXIMENew drugFeb 19, 2021FOR SUSPENSION, ORAL |
| CEFDINIRNew drugFeb 19, 2021FOR SUSPENSION, ORAL |
| CEFDINIRNew drugFeb 19, 2021CAPSULE, ORAL |
| DROXIDOPANew drugFeb 18, 2021CAPSULE, ORAL |