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Hikma FDA Approvals
73 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 |
|---|
| DEFLAZACORTNew drugSep 18, 2026TABLET, ORAL |
| SUGAMMADEX SODIUMNew drugJul 28, 2026SOLUTION, INTRAVENOUS |
| SUGAMMADEX SODIUMNew drugJul 28, 2026SOLUTION, INTRAVENOUS |
| SOLRIAMFETOL HYDROCHLORIDENew drugJun 17, 2026TABLET, ORAL |
| EPINEPHRINENew drugMay 29, 2026SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| ELTROMBOPAG OLAMINENew drugApr 8, 2026TABLET, ORAL |
| TAPENTADOL HYDROCHLORIDENew drugFeb 10, 2026TABLET, ORAL |
| AZTREONAMNew drugFeb 5, 2026INJECTABLE, INJECTION |
| ATROPINE SULFATENew drugOct 24, 2025SOLUTION, INTRAVENOUS |
| PRUCALOPRIDE SUCCINATENew drugJun 24, 2025TABLET, ORAL |
| SAPROPTERIN DIHYDROCHLORIDENew drugJun 11, 2025TABLET, ORAL |
| METHADONE HYDROCHLORIDENew drugMay 5, 2025INJECTABLE, INJECTION |
| METHYLPREDNISOLONE ACETATENew drugApr 16, 2025INJECTABLE, INJECTION |
| MERCAPTOPURINENew drugFeb 26, 2025SUSPENSION, ORAL |
| ERTUGLIFLOZINNew drugJan 21, 2025TABLET, ORAL |
| LIRAGLUTIDENew drugDec 23, 2024SOLUTION, SUBCUTANEOUS |
| PHYTONADIONENew drugDec 19, 2024TABLET, ORAL |
| METHYLENE BLUENew drugDec 17, 2024SOLUTION, INTRAVENOUS |
| TRIAMCINOLONE ACETONIDENew drugDec 9, 2024INJECTABLE, INJECTION |
| INDOMETHACINNew drugNov 19, 2024SUPPOSITORY, RECTAL |
| EPHEDRINE SULFATENew drugOct 11, 2024SOLUTION, INTRAVENOUS |
| ROPIVACAINE HYDROCHLORIDENew drugAug 15, 2024SOLUTION, INJECTION |
| TRAMETINIB DIMETHYL SULFOXIDENew drugAug 6, 2024TABLET, ORAL |
| SUCRALFATENew drugJul 23, 2024SUSPENSION, ORAL |
| CEFEPIME HYDROCHLORIDENew drugMay 22, 2024INJECTABLE, INJECTION |
| EDARAVONENew drugMay 6, 2024INJECTION, SOLUTION |
| LACOSAMIDENew drugApr 5, 2024SOLUTION, INTRAVENOUS |
| SODIUM ACETATENew drugMar 15, 2024SOLUTION, INTRAVENOUS |
| LEVETIRACETAM IN SODIUM CHLORIDENew drugFeb 12, 2024INJECTABLE, INTRAVENOUS |
| HYDROMORPHONE HYDROCHLORIDENew drugFeb 9, 2024INJECTABLE, INJECTION |
| CYCLOPHOSPHAMIDENew drugDec 18, 2023INJECTABLE, INJECTION |
| HYDROMORPHONE HYDROCHLORIDENew drugDec 14, 2023SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| LOTEPREDNOL ETABONATENew drugNov 29, 2023GEL, OPHTHALMIC |
| COMBOGESIC IVNew drugOct 17, 2023SOLUTION, INTRAVENOUS |
| TOFACITINIB CITRATENew drugSep 25, 2023SOLUTION, ORAL |
| THIOTEPANew drugSep 5, 2023POWDER, INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
| ALVIMOPANNew drugAug 31, 2023CAPSULE, ORAL |
| LISDEXAMFETAMINE DIMESYLATENew drugAug 25, 2023CAPSULE, ORAL |
| DEXAMETHASONE SODIUM PHOSPHATENew drugAug 1, 2023INJECTABLE, INJECTION |
| VANCOMYCIN HYDROCHLORIDENew drugJun 29, 2023POWDER, INTRAVENOUS |
| ROCURONIUM BROMIDENew drugMay 24, 2023INJECTABLE, INJECTION |
| ISOPROTERENOL HYDROCHLORIDENew drugApr 26, 2023INJECTABLE, INJECTION |
| CISATRACURIUM BESYLATENew drugApr 19, 2023INJECTABLE, INJECTION |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDENew drugApr 17, 2023SOLUTION, INTRAVENOUS |
| CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%New drugApr 5, 2023INJECTABLE, INJECTION |
| GEMCITABINE HYDROCHLORIDENew drugMar 7, 2023INJECTABLE, INJECTION |
| REGADENOSONNew drugFeb 2, 2023SOLUTION, INTRAVENOUS |
| STERILE WATER FOR INJECTIONNew drugJan 31, 2023LIQUID, N/A |
| DAPTOMYCINNew drugJan 30, 2023POWDER, INTRAVENOUS |
| BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATENew drugJan 17, 2023INJECTABLE, INJECTION |
| MORPHINE SULFATENew drugJan 12, 2023INJECTABLE, INJECTION |
| MEDROXYPROGESTERONE ACETATENew drugJan 5, 2023INJECTABLE, INJECTION |
| PROCHLORPERAZINE EDISYLATENew drugNov 22, 2022INJECTABLE, INJECTION |
| CEFAZOLIN SODIUMNew drugOct 7, 2022POWDER, INTRAVENOUS |
| METHYLPREDNISOLONE SODIUM SUCCINATENew drugSep 26, 2022INJECTABLE, INJECTION |
| VIGABATRINNew drugAug 29, 2022TABLET, ORAL |
| LINEZOLIDNew drugAug 22, 2022SOLUTION, INTRAVENOUS |
| NEOSTIGMINE METHYLSULFATENew drugJul 13, 2022SOLUTION, INTRAVENOUS |
| CISATRACURIUM BESYLATENew drugJun 28, 2022INJECTABLE, INJECTION |
| NALOXONE HYDROCHLORIDENew drugJun 10, 2022INJECTABLE, INJECTION |
| ACETAMINOPHENNew drugJun 3, 2022SOLUTION, INTRAVENOUS |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINENew drugMar 25, 2022CAPSULE, ORAL |
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATENew drugJan 26, 2022CAPSULE, ORAL |
| ATROPINE SULFATENew drugDec 1, 2021SOLUTION, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL |
| BENZTROPINE MESYLATENew drugOct 14, 2021INJECTABLE, INJECTION |
| VANCOMYCINNew drugAug 26, 2021SOLUTION, INTRAVENOUS, ORAL |
| SUCCINYLCHOLINE CHLORIDENew drugAug 20, 2021SOLUTION, INTRAMUSCULAR, INTRAVENOUS |
| MICAFUNGIN SODIUMNew drugJul 9, 2021INJECTABLE, INTRAVENOUS |
| LEVOTHYROXINE SODIUMNew drugMay 17, 2021SOLUTION, INTRAVENOUS |
| KLOXXADONew drugApr 29, 2021SPRAY, NASAL |
| DEFERIPRONENew drugMar 29, 2021TABLET, ORAL |
| DROXIDOPANew drugFeb 18, 2021CAPSULE, ORAL |
| DOCETAXELNew drugJan 14, 2021INJECTABLE, INJECTION |