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Mylan FDA Approvals
30 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 |
|---|
| SUGAMMADEX SODIUMNew drugJul 28, 2026SOLUTION, INTRAVENOUS |
| FERRIC CARBOXYMALTOSENew drugJun 25, 2026SOLUTION, INTRAVENOUS |
| FERRIC CARBOXYMALTOSENew drugJun 25, 2026SOLUTION, INTRAVENOUS |
| APREPITANTNew drugMar 5, 2026EMULSION, INTRAVENOUS |
| MACITENTANNew drugDec 3, 2025TABLET, ORAL |
| LINAGLIPTINNew drugNov 3, 2025TABLET, ORAL |
| PACLITAXELNew drugAug 19, 2025POWDER, INTRAVENOUS |
| DARUNAVIRNew drugJul 22, 2025TABLET, ORAL |
| EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATENew drugMay 20, 2025TABLET, ORAL |
| DABIGATRAN ETEXILATE MESYLATENew drugFeb 3, 2025CAPSULE, ORAL |
| ARIPIPRAZOLENew drugDec 3, 2024FOR SUSPENSION, EXTENDED RELEASE, INTRAMUSCULAR |
| EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATENew drugSep 5, 2024TABLET, ORAL |
| EPOPROSTENOL SODIUMNew drugJun 12, 2024INJECTABLE, INJECTION |
| DEXLANSOPRAZOLENew drugJan 19, 2024CAPSULE, DELAYED RELEASE, ORAL |
| LISDEXAMFETAMINE DIMESYLATENew drugAug 25, 2023CAPSULE, ORAL |
| DAPTOMYCINNew drugAug 7, 2023POWDER, INTRAVENOUS |
| SAXAGLIPTINNew drugJul 31, 2023TABLET, ORAL |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDENew drugJul 31, 2023TABLET, EXTENDED RELEASE, ORAL |
| REGADENOSONNew drugApr 4, 2023SOLUTION, INTRAVENOUS |
| SUCRALFATENew drugSep 12, 2022SUSPENSION, ORAL |
| LENALIDOMIDENew drugAug 30, 2022CAPSULE, ORAL |
| ERMEZANew drugApr 29, 2022SOLUTION, ORAL |
| BREYNANew drugMar 15, 2022AEROSOL, METERED, INHALATION |
| DAPSONENew drugFeb 4, 2022GEL, TOPICAL |
| CYCLOSPORINENew drugFeb 2, 2022EMULSION, OPHTHALMIC |
| POMALIDOMIDENew drugJan 26, 2022CAPSULE, ORAL |
| SUNITINIB MALATENew drugDec 6, 2021CAPSULE, ORAL |
| TICAGRELORNew drugJul 9, 2021TABLET, ORAL |
| LINACLOTIDENew drugFeb 9, 2021CAPSULE, ORAL |
| FINGOLIMOD HYDROCHLORIDENew drugJan 19, 2021CAPSULE, ORAL |