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Caplin FDA Approvals

36 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
FOSCARNET SODIUMNew drugMay 13, 2026SOLUTION, INTRAVENOUS
CALCIUM GLUCONATENew drugMay 4, 2026SOLUTION, INTRAVENOUS
POTASSIUM PHOSPHATESNew drugMar 12, 2026SOLUTION, INTRAVENOUS
DESMOPRESSIN ACETATENew drugFeb 27, 2026INJECTABLE, INJECTION
SODIUM PHOSPHATESNew drugFeb 23, 2026SOLUTION, INTRAVENOUS
METHYLPREDNISOLONE ACETATENew drugJan 26, 2026INJECTABLE, INJECTION
LINEZOLIDNew drugDec 8, 2025SOLUTION, INTRAVENOUS
ACETAMINOPHENNew drugDec 5, 2025SOLUTION, INTRAVENOUS
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDENew drugOct 22, 2025INJECTABLE, INTRAVENOUS
MILRINONE LACTATE IN DEXTROSE 5%New drugSep 2, 2025INJECTABLE, INJECTION
KETAMINE HYDROCHLORIDENew drugAug 7, 2025INJECTABLE, INJECTION
HALOPERIDOL DECANOATENew drugMay 13, 2025INJECTABLE, INJECTION
PHYTONADIONENew drugApr 17, 2025INJECTABLE, INJECTION
BRIMONIDINE TARTRATE AND TIMOLOL MALEATENew drugFeb 25, 2025SOLUTION/DROPS, OPHTHALMIC
PROCAINAMIDE HYDROCHLORIDENew drugFeb 4, 2025INJECTABLE, INJECTION
LEVETIRACETAM IN SODIUM CHLORIDENew drugJan 16, 2025INJECTABLE, INTRAVENOUS
DIFLUPREDNATENew drugDec 13, 2024EMULSION, OPHTHALMIC
TIMOLOL MALEATENew drugAug 7, 2024SOLUTION/DROPS, OPHTHALMIC
EPHEDRINE SULFATENew drugJul 18, 2024SOLUTION, INTRAVENOUS
PHENYLEPHRINE HYDROCHLORIDENew drugMay 23, 2024SOLUTION/DROPS, OPHTHALMIC
OFLOXACINNew drugApr 12, 2024SOLUTION/DROPS, OPHTHALMIC
KETOROLAC TROMETHAMINENew drugMar 26, 2024SOLUTION/DROPS, OPHTHALMIC
OFLOXACINNew drugJan 5, 2024SOLUTION/DROPS, OTIC
NOREPINEPHRINE BITARTRATENew drugSep 15, 2023INJECTABLE, INJECTION
CISATRACURIUM BESYLATENew drugJun 9, 2023INJECTABLE, INJECTION
KETOROLAC TROMETHAMINENew drugMay 10, 2023INJECTABLE, INJECTION
THIAMINE HYDROCHLORIDENew drugMar 6, 2023INJECTABLE, INJECTION
ROCURONIUM BROMIDENew drugMar 2, 2023INJECTABLE, INJECTION
CARBOPROST TROMETHAMINENew drugFeb 13, 2023INJECTABLE, INJECTION
GATIFLOXACINNew drugNov 3, 2021SOLUTION/DROPS, OPHTHALMIC
LABETALOL HYDROCHLORIDENew drugSep 7, 2021INJECTABLE, INJECTION
SUMATRIPTAN SUCCINATENew drugJul 13, 2021INJECTABLE, SUBCUTANEOUS
PROCHLORPERAZINE EDISYLATENew drugApr 22, 2021INJECTABLE, INJECTION
NEOSTIGMINE METHYLSULFATENew drugApr 20, 2021SOLUTION, INTRAVENOUS
MILRINONE LACTATENew drugApr 16, 2021INJECTABLE, INJECTION
ARGATROBANNew drugJan 21, 2021INJECTABLE, INJECTION

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