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Amneal FDA Approvals
125 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 |
|---|
| LANREOTIDE ACETATENew drugSep 18, 2026SOLUTION, SUBCUTANEOUS |
| SODIUM BICARBONATENew drugJul 9, 2026SOLUTION, INTRAVENOUS |
| MACITENTANNew drugJun 8, 2026TABLET, ORAL |
| ROMIDEPSINNew drugJun 2, 2026SOLUTION, INTRAVENOUS |
| PHYTONADIONENew drugJun 1, 2026INJECTABLE, INJECTION |
| TRETINOINNew drugMay 14, 2026GEL, TOPICAL |
| SERTRALINE HYDROCHLORIDENew drugJan 28, 2026CAPSULE, ORAL |
| CUPRIC CHLORIDENew drugJan 26, 2026INJECTABLE, INJECTION |
| ELTROMBOPAG OLAMINENew drugJan 14, 2026TABLET, ORAL |
| SODIUM BICARBONATENew drugJan 13, 2026SOLUTION, INTRAVENOUS |
| DEFLAZACORTNew drugDec 12, 2025TABLET, ORAL |
| EPINEPHRINENew drugDec 8, 2025SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| CYCLOSPORINENew drugNov 28, 2025EMULSION, OPHTHALMIC |
| IOHEXOLNew drugNov 13, 2025SOLUTION, INJECTION, ORAL, RECTAL |
| PHYTONADIONENew drugNov 4, 2025INJECTABLE, INJECTION |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONENew drugOct 29, 2025SOLUTION/DROPS, OTIC |
| EPINEPHRINENew drugOct 14, 2025SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| LABETALOL HYDROCHLORIDENew drugOct 2, 2025INJECTABLE, INJECTION |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONENew drugSep 30, 2025SUSPENSION/DROPS, OTIC |
| CALCITONIN-SALMONNew drugSep 26, 2025INJECTABLE, INJECTION |
| BIMATOPROSTNew drugSep 22, 2025SOLUTION/DROPS, OPHTHALMIC |
| SODIUM OXYBATENew drugSep 10, 2025SOLUTION, ORAL |
| RISPERIDONENew drugSep 2, 2025POWDER, INTRAMUSCULAR |
| PENCICLOVIRNew drugAug 22, 2025CREAM, TOPICAL |
| SODIUM ACETATENew drugAug 8, 2025SOLUTION, INTRAVENOUS |
| PRUCALOPRIDE SUCCINATENew drugJun 24, 2025TABLET, ORAL |
| PREDNISOLONE ACETATENew drugJun 11, 2025SUSPENSION/DROPS, OPHTHALMIC |
| SCOPOLAMINENew drugJun 9, 2025SYSTEM, TRANSDERMAL |
| LOTEPREDNOL ETABONATENew drugMay 20, 2025SUSPENSION/DROPS, OPHTHALMIC |
| BREKIYA (AUTOINJECTOR)New drugMay 14, 2025SOLUTION, SUBCUTANEOUS |
| PILOCARPINE HYDROCHLORIDENew drugApr 28, 2025SOLUTION/DROPS, OPHTHALMIC |
| INDOMETHACINNew drugFeb 24, 2025SUPPOSITORY, RECTAL |
| MESALAMINENew drugFeb 18, 2025TABLET, DELAYED RELEASE, ORAL |
| LENALIDOMIDENew drugJan 31, 2025CAPSULE, ORAL |
| EVEROLIMUSNew drugJan 10, 2025TABLET, FOR SUSPENSION, ORAL |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATENew drugDec 30, 2024SOLUTION/DROPS, OPHTHALMIC |
| LOTEPREDNOL ETABONATENew drugDec 13, 2024SUSPENSION/DROPS, OPHTHALMIC |
| DOXYCYCLINE HYCLATENew drugDec 4, 2024INJECTABLE, INJECTION |
| EXENATIDE SYNTHETICNew drugNov 19, 2024INJECTABLE, SUBCUTANEOUS |
| NICARDIPINE HYDROCHLORIDENew drugOct 31, 2024INJECTABLE, INJECTION |
| PYRIDOSTIGMINE BROMIDENew drugOct 4, 2024TABLET, EXTENDED RELEASE, ORAL |
| PROPOFOLNew drugAug 15, 2024INJECTABLE, INJECTION |
| BROMFENAC SODIUMNew drugJul 29, 2024SOLUTION/DROPS, OPHTHALMIC |
| POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDENew drugJul 26, 2024SOLUTION, INTRAVENOUS |
| ESTRADIOLNew drugJul 12, 2024GEL, TRANSDERMAL |
| CALCIUM CHLORIDE 10%New drugJul 8, 2024INJECTABLE, INJECTION |
| CABERGOLINENew drugJun 25, 2024TABLET, ORAL |
| AZELASTINE HYDROCHLORIDENew drugJun 5, 2024SPRAY, METERED, NASAL |
| TIMOLOL MALEATENew drugMay 23, 2024SOLUTION, GEL FORMING/DROPS, OPHTHALMIC |
| CALCIUM GLUCONATENew drugMay 10, 2024SOLUTION, INTRAVENOUS |
| NALOXONE HYDROCHLORIDENew drugApr 23, 2024SPRAY, METERED, NASAL |
| NICARDIPINE HYDROCHLORIDENew drugApr 10, 2024CAPSULE, ORAL |
| FOSFOMYCIN TROMETHAMINENew drugMar 25, 2024FOR SOLUTION, ORAL |
| CIPROFLOXACIN AND DEXAMETHASONENew drugMar 22, 2024SUSPENSION/DROPS, OTIC |
| FOSCARNET SODIUMNew drugMar 1, 2024SOLUTION, INTRAVENOUS |
| OFLOXACINNew drugMar 1, 2024SOLUTION/DROPS, OPHTHALMIC |
| FLUOROMETHOLONENew drugJan 9, 2024SUSPENSION/DROPS, OPHTHALMIC |
| DARUNAVIRNew drugDec 8, 2023TABLET, ORAL |
| METHYLPREDNISOLONE ACETATENew drugNov 3, 2023INJECTABLE, INJECTION |
| DAPSONENew drugOct 19, 2023GEL, TOPICAL |
| TRANEXAMIC ACIDNew drugOct 16, 2023SOLUTION, INTRAVENOUS |
| POTASSIUM PHOSPHATESNew drugOct 10, 2023SOLUTION, INTRAVENOUS |
| SPIRONOLACTONENew drugSep 5, 2023SUSPENSION, ORAL |
| CALCIUM GLUCONATE IN SODIUM CHLORIDENew drugSep 5, 2023SOLUTION, INTRAVENOUS |
| LISDEXAMFETAMINE DIMESYLATENew drugAug 25, 2023CAPSULE, ORAL |
| DOXEPIN HYDROCHLORIDENew drugAug 16, 2023CREAM, TOPICAL |
| TIOPRONINNew drugAug 15, 2023TABLET, DELAYED RELEASE, ORAL |
| SAXAGLIPTINNew drugJul 31, 2023TABLET, ORAL |
| PLERIXAFORNew drugJul 24, 2023SOLUTION, SUBCUTANEOUS |
| OLMESARTAN MEDOXOMILNew drugJul 11, 2023TABLET, ORAL |
| VANCOMYCIN HYDROCHLORIDENew drugJun 23, 2023FOR SOLUTION, ORAL |
| MOMETASONE FUROATENew drugJun 14, 2023SPRAY, METERED, NASAL |
| AMLODIPINE BENZOATENew drugJun 13, 2023SUSPENSION, ORAL |
| MEDROXYPROGESTERONE ACETATENew drugJun 7, 2023INJECTABLE, INJECTION |
| DAPSONENew drugMay 31, 2023GEL, TOPICAL |
| METRONIDAZOLE IN PLASTIC CONTAINERNew drugMay 24, 2023INJECTABLE, INJECTION |
| DEXMEDETOMIDINE HYDROCHLORIDENew drugMay 15, 2023INJECTABLE, INJECTION |
| PROCHLORPERAZINE MALEATENew drugApr 17, 2023TABLET, ORAL |
| NELARABINENew drugApr 4, 2023INJECTABLE, INTRAVENOUS |
| THEOPHYLLINENew drugMar 20, 2023TABLET, EXTENDED RELEASE, ORAL |
| ROPIVACAINE HYDROCHLORIDENew drugMar 8, 2023SOLUTION, INJECTION |
| MAGNESIUM SULFATE IN PLASTIC CONTAINERNew drugFeb 15, 2023INJECTABLE, INJECTION |
| BREXPIPRAZOLENew drugJan 31, 2023TABLET, ORAL |
| POSACONAZOLENew drugDec 22, 2022TABLET, DELAYED RELEASE, ORAL |
| ESMOLOL HYDROCHLORIDENew drugDec 13, 2022INJECTABLE, INJECTION |
| PROCHLORPERAZINE EDISYLATENew drugNov 28, 2022INJECTABLE, INJECTION |
| MUPIROCINNew drugNov 15, 2022CREAM, TOPICAL |
| CLINDAMYCIN PHOSPHATENew drugNov 3, 2022GEL, TOPICAL |
| LEUPROLIDE ACETATENew drugOct 28, 2022SOLUTION, SUBCUTANEOUS |
| PREDNISOLONE SODIUM PHOSPHATENew drugOct 25, 2022SOLUTION, ORAL |
| DOXYCYCLINE HYCLATENew drugOct 24, 2022TABLET, ORAL |
| GLYCOPYRROLATENew drugOct 21, 2022INJECTABLE, INJECTION |
| DEXAMETHASONENew drugSep 8, 2022TABLET, ORAL |
| DICLOFENAC SODIUMNew drugAug 18, 2022SOLUTION, TOPICAL |
| IPRATROPIUM BROMIDENew drugAug 16, 2022SPRAY, METERED, NASAL |
| IPRATROPIUM BROMIDENew drugAug 16, 2022SPRAY, METERED, NASAL |
| CLINDAMYCIN PHOSPHATENew drugAug 5, 2022GEL, TOPICAL |
| VASOPRESSINNew drugAug 5, 2022SOLUTION, INTRAVENOUS |
| FAMOTIDINENew drugAug 4, 2022FOR SUSPENSION, ORAL |
| PEMETREXED DISODIUMNew drugAug 4, 2022POWDER, INTRAVENOUS |
| ATROPINE SULFATENew drugJul 14, 2022SOLUTION/DROPS, OPHTHALMIC |
| ENALAPRIL MALEATENew drugJun 29, 2022SOLUTION, ORAL |
| BEXAROTENENew drugApr 27, 2022GEL, TOPICAL |
| PIRFENIDONENew drugMar 25, 2022TABLET, ORAL |
| THIOTHIXENENew drugFeb 28, 2022CAPSULE, ORAL |
| AZACITIDINENew drugFeb 3, 2022POWDER, INTRAVENOUS, SUBCUTANEOUS |
| CARBOPROST TROMETHAMINENew drugJan 27, 2022INJECTABLE, INJECTION |
| ATROPINE SULFATENew drugJan 26, 2022SOLUTION, INTRAVENOUS |
| DIHYDROERGOTAMINE MESYLATENew drugJan 4, 2022SPRAY, METERED, NASAL |
| PIRFENIDONENew drugJan 3, 2022CAPSULE, ORAL |
| LUBIPROSTONENew drugNov 30, 2021CAPSULE, ORAL |
| DIFLUPREDNATENew drugNov 17, 2021EMULSION, OPHTHALMIC |
| MYCOPHENOLATE MOFETILNew drugNov 2, 2021FOR SUSPENSION, ORAL |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDENew drugOct 25, 2021CAPSULE, ORAL |
| DEXAMETHASONENew drugOct 14, 2021TABLET, ORAL |
| METHYLPREDNISOLONENew drugSep 21, 2021TABLET, ORAL |
| TOBRAMYCIN AND DEXAMETHASONENew drugJul 15, 2021SUSPENSION/DROPS, OPHTHALMIC |
| APREMILASTNew drugJun 30, 2021TABLET, ORAL |
| CLOBETASOL PROPIONATENew drugJun 14, 2021SHAMPOO, TOPICAL |
| ETRAVIRINENew drugJun 14, 2021TABLET, ORAL |
| RANOLAZINENew drugMar 11, 2021TABLET, EXTENDED RELEASE, ORAL |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDENew drugMar 5, 2021INJECTABLE, INJECTION |
| ETHINYL ESTRADIOL AND NORELGESTROMINNew drugFeb 25, 2021FILM, EXTENDED RELEASE, TRANSDERMAL |
| DEFERASIROXNew drugFeb 9, 2021GRANULE, ORAL |
| ARSENIC TRIOXIDENew drugJan 25, 2021INJECTABLE, INJECTION |