← Every applicant
Alembic FDA Approvals
111 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 |
|---|
| PRUCALOPRIDE SUCCINATENew drugJul 27, 2026TABLET, ORAL |
| OSELTAMIVIR PHOSPHATENew drugJun 25, 2026FOR SUSPENSION, ORAL |
| DAPSONENew drugJun 25, 2026GEL, TOPICAL |
| TRETINOINNew drugJun 11, 2026CREAM, TOPICAL |
| HALOPERIDOLNew drugJun 4, 2026TABLET, ORAL |
| LEVOTHYROXINE SODIUMNew drugMay 20, 2026TABLET, ORAL |
| FINGOLIMOD HYDROCHLORIDENew drugApr 24, 2026CAPSULE, ORAL |
| METHOTREXATE SODIUMNew drugApr 15, 2026INJECTABLE, INJECTION |
| DAPAGLIFLOZINNew drugApr 6, 2026TABLET, ORAL |
| LAMOTRIGINENew drugFeb 25, 2026TABLET, ORALLY DISINTEGRATING, ORAL |
| EFINACONAZOLENew drugFeb 23, 2026SOLUTION, TOPICAL |
| CARBIDOPA, LEVODOPA AND ENTACAPONENew drugFeb 5, 2026TABLET, ORAL |
| DIFLUPREDNATENew drugJan 26, 2026EMULSION, OPHTHALMIC |
| TRAVOPROSTNew drugDec 17, 2025SOLUTION/DROPS, OPHTHALMIC |
| LOTEPREDNOL ETABONATE AND TOBRAMYCINNew drugDec 10, 2025SUSPENSION/DROPS, OPHTHALMIC |
| DILTIAZEM HYDROCHLORIDENew drugNov 14, 2025TABLET, ORAL |
| DEXLANSOPRAZOLENew drugNov 12, 2025CAPSULE, DELAYED RELEASE, ORAL |
| DASATINIBNew drugNov 6, 2025TABLET, ORAL |
| SUMATRIPTAN SUCCINATE (AUTOINJECTOR)New drugNov 6, 2025INJECTABLE, SUBCUTANEOUS |
| TRIAMCINOLONE ACETONIDENew drugOct 17, 2025INJECTABLE, INJECTION |
| PAROXETINE HYDROCHLORIDENew drugSep 24, 2025TABLET, EXTENDED RELEASE, ORAL |
| PHYTONADIONENew drugSep 8, 2025INJECTABLE, INJECTION |
| MACITENTANNew drugAug 18, 2025TABLET, ORAL |
| TRETINOINNew drugAug 14, 2025CREAM, TOPICAL |
| CARBAMAZEPINENew drugJul 25, 2025TABLET, EXTENDED RELEASE, ORAL |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)New drugJun 27, 2025INJECTABLE, LIPOSOMAL, INJECTION |
| BOSUTINIB MONOHYDRATENew drugMay 23, 2025TABLET, ORAL |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMNew drugMay 22, 2025TABLET, ORAL |
| RIVAROXABANNew drugMay 14, 2025TABLET, ORAL |
| TICAGRELORNew drugMay 2, 2025TABLET, ORAL |
| CARBAMAZEPINENew drugApr 16, 2025TABLET, ORAL |
| PANTOPRAZOLE SODIUMNew drugMar 31, 2025INJECTABLE, INTRAVENOUS |
| BREXPIPRAZOLENew drugJan 13, 2025TABLET, ORAL |
| DIVALPROEX SODIUMNew drugDec 19, 2024CAPSULE, DELAYED REL PELLETS, ORAL |
| DILTIAZEM HYDROCHLORIDENew drugNov 8, 2024CAPSULE, EXTENDED RELEASE, ORAL |
| IVABRADINE HYDROCHLORIDENew drugNov 8, 2024TABLET, ORAL |
| DILTIAZEM HYDROCHLORIDENew drugOct 18, 2024CAPSULE, EXTENDED RELEASE, ORAL |
| ALCAFTADINENew drugOct 2, 2024SOLUTION/DROPS, OPHTHALMIC |
| LAMOTRIGINENew drugOct 1, 2024TABLET, EXTENDED RELEASE, ORAL |
| PALIPERIDONENew drugSep 26, 2024TABLET, EXTENDED RELEASE, ORAL |
| ALBENDAZOLENew drugSep 4, 2024TABLET, ORAL |
| BETAMETHASONE VALERATENew drugAug 22, 2024AEROSOL, FOAM, TOPICAL |
| ACITRETINNew drugAug 5, 2024CAPSULE, ORAL |
| NELARABINENew drugAug 1, 2024INJECTABLE, INTRAVENOUS |
| FLUPHENAZINE HYDROCHLORIDENew drugJul 23, 2024TABLET, ORAL |
| BROMFENAC SODIUMNew drugJul 8, 2024SOLUTION/DROPS, OPHTHALMIC |
| DOXYCYCLINENew drugJun 27, 2024CAPSULE, ORAL |
| DABIGATRAN ETEXILATE MESYLATENew drugJun 14, 2024CAPSULE, ORAL |
| ICATIBANT ACETATENew drugJun 14, 2024INJECTABLE, SUBCUTANEOUS |
| VENLAFAXINE HYDROCHLORIDENew drugJun 6, 2024CAPSULE, EXTENDED RELEASE, ORAL |
| METHOTREXATE SODIUMNew drugJun 3, 2024TABLET, ORAL |
| SACUBITRIL AND VALSARTANNew drugMay 28, 2024TABLET, ORAL |
| TRETINOINNew drugApr 29, 2024CREAM, TOPICAL |
| DIAZEPAMNew drugApr 25, 2024INJECTABLE, INJECTION |
| CLINDAMYCIN PHOSPHATENew drugApr 2, 2024GEL, TOPICAL |
| ACYCLOVIRNew drugNov 21, 2023CREAM, TOPICAL |
| DAPSONENew drugOct 27, 2023GEL, TOPICAL |
| CARMUSTINENew drugOct 20, 2023INJECTABLE, INJECTION |
| FLUOROURACILNew drugOct 18, 2023INJECTABLE, INJECTION |
| SELEXIPAGNew drugOct 11, 2023TABLET, ORAL |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDENew drugSep 15, 2023CAPSULE, ORAL |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATENew drugAug 25, 2023SOLUTION/DROPS, OPHTHALMIC |
| ERYTHROMYCINNew drugAug 24, 2023TABLET, ORAL |
| GUANFACINE HYDROCHLORIDENew drugAug 7, 2023TABLET, EXTENDED RELEASE, ORAL |
| BRIMONIDINE TARTRATENew drugAug 1, 2023SOLUTION/DROPS, OPHTHALMIC |
| CHLORPROMAZINE HYDROCHLORIDENew drugJul 18, 2023TABLET, ORAL |
| DOXERCALCIFEROLNew drugJun 15, 2023INJECTABLE, INJECTION |
| CARBOPROST TROMETHAMINENew drugJun 15, 2023INJECTABLE, INJECTION |
| NADOLOLNew drugJun 2, 2023TABLET, ORAL |
| BEPOTASTINE BESILATENew drugApr 5, 2023SOLUTION/DROPS, OPHTHALMIC |
| BRIMONIDINE TARTRATENew drugMar 29, 2023SOLUTION/DROPS, OPHTHALMIC |
| PRAZOSIN HYDROCHLORIDENew drugMar 6, 2023CAPSULE, ORAL |
| FLUOROURACILNew drugMar 3, 2023INJECTABLE, INJECTION |
| DOCETAXELNew drugFeb 28, 2023INJECTABLE, INJECTION |
| FESOTERODINE FUMARATENew drugJan 4, 2023TABLET, EXTENDED RELEASE, ORAL |
| FULVESTRANTNew drugDec 22, 2022SOLUTION, INTRAMUSCULAR |
| DESONIDENew drugDec 8, 2022CREAM, TOPICAL |
| DICLOFENAC SODIUMNew drugNov 29, 2022SOLUTION, TOPICAL |
| NIFEDIPINENew drugNov 18, 2022TABLET, EXTENDED RELEASE, ORAL |
| CYCLOPHOSPHAMIDENew drugNov 10, 2022CAPSULE, ORAL |
| KETOROLAC TROMETHAMINENew drugNov 2, 2022INJECTABLE, INJECTION |
| MESALAMINENew drugOct 28, 2022CAPSULE, EXTENDED RELEASE, ORAL |
| GLYCOPYRROLATENew drugOct 26, 2022INJECTABLE, INJECTION |
| PACLITAXELNew drugOct 20, 2022INJECTABLE, INJECTION |
| CHLORTHALIDONENew drugAug 26, 2022TABLET, ORAL |
| ADAPALENE AND BENZOYL PEROXIDENew drugAug 4, 2022GEL, TOPICAL |
| DICLOFENAC SODIUMNew drugJul 27, 2022GEL, TOPICAL |
| PIRFENIDONENew drugMay 20, 2022TABLET, ORAL |
| ARFORMOTEROL TARTRATENew drugMay 10, 2022SOLUTION, INHALATION |
| DOCOSANOLNew drugMay 3, 2022CREAM, TOPICAL |
| CLOBETASOL PROPIONATENew drugApr 21, 2022AEROSOL, FOAM, TOPICAL |
| LIDOCAINE AND PRILOCAINENew drugApr 8, 2022CREAM, TOPICAL |
| LACOSAMIDENew drugMar 17, 2022TABLET, ORAL |
| NYSTATIN AND TRIAMCINOLONE ACETONIDENew drugMar 4, 2022OINTMENT, TOPICAL |
| CLARITHROMYCINNew drugJan 31, 2022TABLET, ORAL |
| ENTACAPONENew drugJan 4, 2022TABLET, ORAL |
| DOXYCYCLINE HYCLATENew drugJan 3, 2022TABLET, DELAYED RELEASE, ORAL |
| FORMOTEROL FUMARATENew drugNov 22, 2021SOLUTION, INHALATION |
| MUPIROCINNew drugNov 16, 2021CREAM, TOPICAL |
| METRONIDAZOLENew drugSep 3, 2021GEL, TOPICAL |
| CLOMIPRAMINE HYDROCHLORIDENew drugAug 4, 2021CAPSULE, ORAL |
| ERLOTINIB HYDROCHLORIDENew drugJul 8, 2021TABLET, ORAL |
| DESIPRAMINE HYDROCHLORIDENew drugJul 7, 2021TABLET, ORAL |
| NITROFURANTOINNew drugJun 25, 2021CAPSULE, ORAL |
| TESTOSTERONENew drugJun 14, 2021SOLUTION, METERED, TRANSDERMAL |
| LURASIDONE HYDROCHLORIDENew drugMay 13, 2021TABLET, ORAL |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATENew drugMay 4, 2021SOLUTION/DROPS, OPHTHALMIC |
| DOXEPIN HYDROCHLORIDENew drugApr 21, 2021CAPSULE, ORAL |
| NYSTATIN AND TRIAMCINOLONE ACETONIDENew drugMar 31, 2021CREAM, TOPICAL |
| TESTOSTERONENew drugMar 3, 2021GEL, METERED, TRANSDERMAL |
| MIDODRINE HYDROCHLORIDENew drugJan 21, 2021TABLET, ORAL |