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Gland FDA Approvals
82 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 |
|---|
| LEVOCARNITINENew drugSep 30, 2026INJECTABLE, INJECTION |
| ATROPINE SULFATENew drugJul 31, 2026SOLUTION/DROPS, OPHTHALMIC |
| SUGAMMADEX SODIUMNew drugJul 28, 2026SOLUTION, INTRAVENOUS |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATENew drugJun 11, 2026SOLUTION/DROPS, OPHTHALMIC |
| BRIMONIDINE TARTRATENew drugMar 11, 2026SOLUTION/DROPS, OPHTHALMIC |
| ZOLEDRONIC ACIDNew drugFeb 5, 2026INJECTABLE, INTRAVENOUS |
| OLOPATADINE HYDROCHLORIDENew drugJan 6, 2026SOLUTION/DROPS, OPHTHALMIC |
| BORTEZOMIBNew drugJan 6, 2026POWDER, INTRAVENOUS, SUBCUTANEOUS |
| EPOPROSTENOL SODIUMNew drugDec 29, 2025INJECTABLE, INJECTION |
| LEUCOVORIN CALCIUMNew drugNov 12, 2025INJECTABLE, INJECTION |
| CANGRELORNew drugAug 11, 2025POWDER, INTRAVENOUS |
| SELENIOUS ACIDNew drugJul 8, 2025SOLUTION, INTRAVENOUS |
| ACETAZOLAMIDE SODIUMNew drugJun 17, 2025INJECTABLE, INJECTION |
| ANGIOTENSIN ll ACETATENew drugJun 3, 2025SOLUTION, INTRAVENOUS |
| EPINEPHRINENew drugJun 3, 2025INJECTION, SOLUTION,CONCENTRATE |
| LATANOPROSTENE BUNODNew drugApr 29, 2025SOLUTION/DROPS, OPHTHALMIC |
| ACETAMINOPHENNew drugApr 2, 2025SOLUTION, INTRAVENOUS |
| VANCOMYCIN HYDROCHLORIDENew drugMar 21, 2025POWDER, INTRAVENOUS |
| THIAMINE HYDROCHLORIDENew drugFeb 24, 2025INJECTABLE, INJECTION |
| EPINEPHRINENew drugFeb 6, 2025SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| EPHEDRINE SULFATENew drugJan 16, 2025SOLUTION, INTRAVENOUS |
| PHENYLEPHRINE HYDROCHLORIDENew drugDec 18, 2024SOLUTION/DROPS, OPHTHALMIC |
| PHYTONADIONENew drugDec 10, 2024INJECTABLE, INJECTION |
| LATANOPROSTNew drugNov 26, 2024SOLUTION/DROPS, OPHTHALMIC |
| ERYTHROMYCIN LACTOBIONATENew drugNov 19, 2024INJECTABLE, INJECTION |
| CHLORPROMAZINE HYDROCHLORIDENew drugOct 4, 2024INJECTABLE, INJECTION |
| ISOPROTERENOL HYDROCHLORIDENew drugOct 3, 2024INJECTABLE, INJECTION |
| CHLOROTHIAZIDE SODIUMNew drugOct 3, 2024INJECTABLE, INJECTION |
| MIDAZOLAM IN 0.9% SODIUM CHLORIDENew drugAug 12, 2024SOLUTION, INTRAVENOUS |
| PROCAINAMIDE HYDROCHLORIDENew drugJul 22, 2024INJECTABLE, INJECTION |
| TRAVOPROSTNew drugJul 12, 2024SOLUTION/DROPS, OPHTHALMIC |
| EDARAVONENew drugMay 6, 2024SOLUTION, INTRAVENOUS |
| PLERIXAFORNew drugMay 3, 2024SOLUTION, SUBCUTANEOUS |
| CETRORELIX ACETATENew drugApr 25, 2024POWDER, SUBCUTANEOUS |
| TRANEXAMIC ACIDNew drugApr 16, 2024SOLUTION, INTRAVENOUS |
| ERIBULIN MESYLATENew drugApr 5, 2024SOLUTION, INTRAVENOUS |
| DIPHENHYDRAMINE HYDROCHLORIDENew drugMar 20, 2024INJECTABLE, INJECTION |
| ALCAFTADINENew drugMar 1, 2024SOLUTION/DROPS, OPHTHALMIC |
| VASOPRESSIN IN DEXTROSE 5%New drugFeb 9, 2024SOLUTION, INTRAVENOUS |
| NELARABINENew drugJan 3, 2024INJECTABLE, INTRAVENOUS |
| POSACONAZOLENew drugDec 26, 2023SOLUTION, INTRAVENOUS |
| FOSPHENYTOIN SODIUMNew drugOct 13, 2023INJECTABLE, INJECTION |
| DIHYDROERGOTAMINE MESYLATENew drugAug 18, 2023INJECTABLE, INJECTION |
| CARBOPROST TROMETHAMINENew drugAug 7, 2023INJECTABLE, INJECTION |
| ARGATROBANNew drugJul 31, 2023INJECTABLE, INJECTION |
| FOMEPIZOLENew drugJul 6, 2023INJECTABLE, INJECTION |
| OCTREOTIDE ACETATENew drugJun 22, 2023INJECTABLE, INJECTION |
| OCTREOTIDE ACETATENew drugJun 13, 2023INJECTABLE, INJECTION |
| DOXYCYCLINE HYCLATENew drugApr 12, 2023INJECTABLE, INJECTION |
| FLUPHENAZINE DECANOATENew drugMar 30, 2023INJECTABLE, INJECTION |
| DESMOPRESSIN ACETATENew drugMar 20, 2023INJECTABLE, INJECTION |
| GANIRELIX ACETATENew drugFeb 28, 2023INJECTABLE, INJECTION |
| KETAMINE HYDROCHLORIDENew drugJan 24, 2023INJECTABLE, INJECTION |
| MITOMYCINNew drugNov 22, 2022INJECTABLE, INJECTION |
| DESMOPRESSIN ACETATENew drugNov 16, 2022INJECTABLE, INJECTION |
| LINCOMYCIN HYDROCHLORIDENew drugSep 26, 2022INJECTABLE, INJECTION |
| DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATENew drugSep 19, 2022SOLUTION/DROPS, OPHTHALMIC |
| LACOSAMIDENew drugSep 19, 2022SOLUTION, INTRAVENOUS |
| ROPIVACAINE HYDROCHLORIDENew drugAug 18, 2022SOLUTION, INJECTION |
| REGADENOSONNew drugJul 12, 2022SOLUTION, INTRAVENOUS |
| TIMOLOL MALEATENew drugJun 24, 2022SOLUTION, GEL FORMING/DROPS, OPHTHALMIC |
| BUMETANIDENew drugMay 26, 2022INJECTABLE, INJECTION |
| CISATRACURIUM BESYLATENew drugMay 24, 2022INJECTABLE, INJECTION |
| PANTOPRAZOLE SODIUMNew drugMay 18, 2022INJECTABLE, INTRAVENOUS |
| ZINC SULFATENew drugMay 3, 2022SOLUTION, INTRAVENOUS |
| EPHEDRINE SULFATENew drugFeb 25, 2022SOLUTION, INTRAVENOUS |
| DORZOLAMIDE HYDROCHLORIDENew drugJan 27, 2022SOLUTION/DROPS, OPHTHALMIC |
| ALLOPURINOL SODIUMNew drugJan 26, 2022INJECTABLE, INJECTION |
| MITOMYCINNew drugOct 20, 2021INJECTABLE, INJECTION |
| ARSENIC TRIOXIDENew drugOct 7, 2021INJECTABLE, INJECTION |
| PROCHLORPERAZINE EDISYLATENew drugSep 22, 2021INJECTABLE, INJECTION |
| DEXAMETHASONE SODIUM PHOSPHATENew drugAug 4, 2021INJECTABLE, INJECTION |
| DOCETAXELNew drugJul 1, 2021INJECTABLE, INJECTION |
| TOBRAMYCIN SULFATENew drugMay 18, 2021INJECTABLE, INJECTION |
| NOREPINEPHRINE BITARTRATENew drugMay 6, 2021INJECTABLE, INJECTION |
| FOSCARNET SODIUMNew drugApr 21, 2021SOLUTION, INTRAVENOUS |
| TIROFIBAN HYDROCHLORIDENew drugApr 8, 2021SOLUTION, INTRAVENOUS |
| ERTAPENEM SODIUMNew drugMar 26, 2021INJECTABLE, INTRAMUSCULAR, INTRAVENOUS |
| TOBRAMYCINNew drugMar 9, 2021SOLUTION/DROPS, OPHTHALMIC |
| THIOTEPANew drugMar 8, 2021POWDER, INTRACAVITARY, INTRAVENOUS, INTRAVESICAL |
| TOBRAMYCIN SULFATENew drugFeb 11, 2021INJECTABLE, INJECTION |
| TOBRAMYCIN SULFATE (PHARMACY BULK)New drugFeb 9, 2021INJECTABLE, INJECTION |