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Somerset Theraps LLC FDA Approvals
46 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 |
|---|
| VARENICLINE TARTRATENew drugJul 6, 2026TABLET, ORAL |
| TOFACITINIB CITRATENew drugJun 3, 2026TABLET, ORAL |
| CARBOPROST TROMETHAMINENew drugMay 27, 2026INJECTABLE, INJECTION |
| RILPIVIRINE HYDROCHLORIDENew drugJan 29, 2026TABLET, ORAL |
| SACUBITRIL AND VALSARTANNew drugJan 20, 2026TABLET, ORAL |
| ELTROMBOPAG OLAMINENew drugJan 14, 2026TABLET |
| SODIUM ACETATENew drugSep 18, 2025SOLUTION, INTRAVENOUS |
| DIHYDROERGOTAMINE MESYLATENew drugFeb 26, 2025SPRAY, METERED, NASAL |
| PHENYLEPHRINE HYDROCHLORIDENew drugFeb 14, 2025SOLUTION, INTRAVENOUS |
| ACETYLCYSTEINENew drugFeb 12, 2025SOLUTION, INHALATION, ORAL |
| DORZOLAMIDE HYDROCHLORIDENew drugFeb 11, 2025SOLUTION/DROPS, OPHTHALMIC |
| BUPRENORPHINE HYDROCHLORIDENew drugJan 30, 2025INJECTABLE, INJECTION |
| NITROFURANTOINNew drugJan 14, 2025SUSPENSION, ORAL |
| TETRACAINE HYDROCHLORIDENew drugDec 20, 2024SOLUTION, OPHTHALMIC |
| ATROPINE SULFATENew drugNov 29, 2024SOLUTION, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL |
| CHROMIC CHLORIDENew drugNov 18, 2024INJECTABLE, INJECTION |
| MOXIFLOXACIN HYDROCHLORIDENew drugNov 14, 2024SOLUTION/DROPS, OPHTHALMIC |
| DICYCLOMINE HYDROCHLORIDENew drugNov 1, 2024INJECTABLE, INJECTION |
| DICYCLOMINE HYDROCHLORIDENew drugNov 1, 2024INJECTABLE, INJECTION |
| OFLOXACINNew drugOct 15, 2024SOLUTION/DROPS, OTIC |
| LACOSAMIDENew drugOct 9, 2024SOLUTION, INTRAVENOUS |
| TRAVOPROSTNew drugSep 23, 2024SOLUTION/DROPS, OPHTHALMIC |
| NALBUPHINE HYDROCHLORIDENew drugSep 19, 2024SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| NALBUPHINE HYDROCHLORIDENew drugSep 19, 2024SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| TIMOLOL MALEATENew drugSep 16, 2024SOLUTION, GEL FORMING/DROPS, OPHTHALMIC |
| PROCHLORPERAZINE EDISYLATENew drugSep 13, 2024INJECTABLE, INJECTION |
| CABERGOLINENew drugSep 9, 2024TABLET, ORAL |
| BEPOTASTINE BESILATENew drugAug 14, 2024SOLUTION/DROPS, OPHTHALMIC |
| BRIMONIDINE TARTRATENew drugAug 9, 2024SOLUTION/DROPS, OPHTHALMIC |
| PROPARACAINE HYDROCHLORIDENew drugAug 9, 2024SOLUTION/DROPS, OPHTHALMIC |
| ISOPROTERENOL HYDROCHLORIDENew drugAug 6, 2024INJECTABLE, INJECTION |
| TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATENew drugAug 5, 2024SOLUTION/DROPS, OPHTHALMIC |
| ZINC SULFATENew drugJul 17, 2024SOLUTION, INTRAVENOUS |
| POTASSIUM PHOSPHATESNew drugJul 11, 2024SOLUTION, INTRAVENOUS |
| ATROPINE SULFATENew drugJul 3, 2024SOLUTION, INTRAVENOUS |
| TIMOLOL MALEATENew drugJul 3, 2024SOLUTION/DROPS, OPHTHALMIC |
| ATROPINE SULFATENew drugJul 1, 2024SOLUTION/DROPS, OPHTHALMIC |
| VALGANCICLOVIR HYDROCHLORIDENew drugJun 11, 2024TABLET, ORAL |
| ACETYLCYSTEINENew drugJun 7, 2024INJECTABLE, INTRAVENOUS |
| POSACONAZOLENew drugJun 20, 2023TABLET, DELAYED RELEASE, ORAL |
| FAMOTIDINENew drugJun 16, 2023FOR SUSPENSION, ORAL |
| CHLORZOXAZONENew drugJan 27, 2023TABLET, ORAL |
| LEUPROLIDE ACETATENew drugAug 13, 2021SOLUTION, SUBCUTANEOUS |
| VENLAFAXINE HYDROCHLORIDENew drugJun 30, 2021TABLET, EXTENDED RELEASE, ORAL |
| DROXIDOPANew drugMay 5, 2021CAPSULE, ORAL |
| ACETAZOLAMIDENew drugFeb 22, 2021TABLET, ORAL |