← Every applicant
Micro Labs FDA Approvals
64 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 |
|---|
| TOPIRAMATENew drugSep 4, 2026CAPSULE, EXTENDED RELEASE, ORAL |
| RIVAROXABANNew drugJun 30, 2026TABLET, ORAL |
| PRUCALOPRIDE SUCCINATENew drugJun 29, 2026TABLET, ORAL |
| PROPRANOLOL HYDROCHLORIDENew drugJun 24, 2026CAPSULE, EXTENDED RELEASE, ORAL |
| FLUVOXAMINE MALEATENew drugJun 23, 2026CAPSULE, EXTENDED RELEASE, ORAL |
| MIRTAZAPINENew drugMay 19, 2026TABLET, ORAL |
| BRIMONIDINE TARTRATENew drugMay 7, 2026SOLUTION/DROPS, OPHTHALMIC |
| TORSEMIDENew drugMay 1, 2026TABLET, ORAL |
| TICAGRELORNew drugApr 27, 2026TABLET, ORAL |
| FLECAINIDE ACETATENew drugApr 22, 2026TABLET, ORAL |
| ESCITALOPRAM OXALATENew drugApr 22, 2026TABLET, ORAL |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENew drugApr 13, 2026TABLET, ORAL |
| OFLOXACINNew drugApr 8, 2026SOLUTION/DROPS, OPHTHALMIC |
| DAPAGLIFLOZINNew drugApr 6, 2026TABLET, ORAL |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENew drugApr 6, 2026TABLET, EXTENDED RELEASE, ORAL |
| VALGANCICLOVIR HYDROCHLORIDENew drugMar 19, 2026FOR SOLUTION, ORAL |
| BISOPROLOL FUMARATENew drugMar 9, 2026TABLET, ORAL |
| CHOLESTYRAMINENew drugMar 5, 2026POWDER, ORAL |
| BRIVARACETAMNew drugFeb 23, 2026SOLUTION, INTRAVENOUS |
| COLCHICINENew drugFeb 17, 2026CAPSULE, ORAL |
| FUROSEMIDENew drugJan 8, 2026INJECTABLE, INJECTION |
| SAPROPTERIN DIHYDROCHLORIDENew drugJan 8, 2026FOR SOLUTION, ORAL |
| TENOFOVIR DISOPROXIL FUMARATENew drugDec 18, 2025TABLET, ORAL |
| LOPINAVIR AND RITONAVIRNew drugDec 11, 2025TABLET, ORAL |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDENew drugNov 24, 2025TABLET, ORAL |
| VARENICLINE TARTRATENew drugOct 29, 2025TABLET, ORAL |
| PROPARACAINE HYDROCHLORIDENew drugOct 20, 2025SOLUTION/DROPS, OPHTHALMIC |
| DIPHENHYDRAMINE HYDROCHLORIDENew drugAug 22, 2025INJECTABLE, INJECTION |
| LATANOPROSTNew drugApr 14, 2025SOLUTION/DROPS, OPHTHALMIC |
| ARFORMOTEROL TARTRATENew drugMar 7, 2025SOLUTION, INHALATION |
| METOLAZONENew drugNov 6, 2024TABLET, ORAL |
| FORMOTEROL FUMARATENew drugJun 26, 2024SOLUTION, INHALATION |
| CARBOPROST TROMETHAMINENew drugApr 3, 2024INJECTABLE, INJECTION |
| DEXAMETHASONE SODIUM PHOSPHATENew drugMar 27, 2024INJECTABLE, INJECTION |
| AMOXICILLIN AND CLAVULANATE POTASSIUMNew drugDec 8, 2023FOR SUSPENSION, ORAL |
| BRIMONIDINE TARTRATENew drugNov 22, 2023SOLUTION/DROPS, OPHTHALMIC |
| BACLOFENNew drugNov 8, 2023TABLET, ORAL |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)New drugNov 3, 2023CAPSULE, ORAL |
| FAMOTIDINENew drugSep 14, 2023FOR SUSPENSION, ORAL |
| MIDAZOLAM HYDROCHLORIDENew drugAug 21, 2023INJECTABLE, INJECTION |
| LIFITEGRASTNew drugAug 4, 2023SOLUTION/DROPS, OPHTHALMIC |
| TOBRAMYCINNew drugJul 27, 2023SOLUTION, INHALATION |
| NICARDIPINE HYDROCHLORIDENew drugJul 7, 2023INJECTABLE, INJECTION |
| DOXEPIN HYDROCHLORIDENew drugJun 27, 2023CAPSULE, ORAL |
| TIMOLOL MALEATENew drugMay 26, 2023SOLUTION/DROPS, OPHTHALMIC |
| RUFINAMIDENew drugMay 15, 2023TABLET, ORAL |
| TOFACITINIB CITRATENew drugMar 13, 2023TABLET, ORAL |
| RAMELTEONNew drugFeb 9, 2023TABLET, ORAL |
| METFORMIN HYDROCHLORIDENew drugJan 10, 2023TABLET, EXTENDED RELEASE, ORAL |
| MISOPROSTOLNew drugOct 17, 2022TABLET, ORAL |
| TIMOLOL MALEATENew drugSep 7, 2022SOLUTION/DROPS, OPHTHALMIC |
| CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDENew drugJul 19, 2022CAPSULE, ORAL |
| AMOXICILLINNew drugJun 24, 2022CAPSULE, ORAL |
| PIRFENIDONENew drugMay 18, 2022TABLET, ORAL |
| CROMOLYN SODIUMNew drugApr 29, 2022SOLUTION, INHALATION |
| FLUOXETINE HYDROCHLORIDENew drugMar 29, 2022CAPSULE, ORAL |
| SEVELAMER CARBONATENew drugFeb 7, 2022TABLET, ORAL |
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDENew drugFeb 2, 2022TABLET, ORAL |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATENew drugJan 25, 2022SOLUTION/DROPS, OPHTHALMIC |
| LINCOMYCIN HYDROCHLORIDENew drugNov 8, 2021INJECTABLE, INJECTION |
| ASPIRIN AND DIPYRIDAMOLENew drugAug 11, 2021CAPSULE, EXTENDED RELEASE, ORAL |
| DICLOFENAC SODIUM AND MISOPROSTOLNew drugJul 15, 2021TABLET, DELAYED RELEASE, ORAL |
| TRAVOPROSTNew drugMar 19, 2021SOLUTION/DROPS, OPHTHALMIC |
| ISOPROTERENOL HYDROCHLORIDENew drugFeb 16, 2021INJECTABLE, INJECTION |