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Unichem FDA Approvals

24 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
ALPRAZOLAMNew drugJul 13, 2026TABLET, ORAL
PREGABALINNew drugApr 30, 2026CAPSULE, ORAL
GUANFACINE HYDROCHLORIDENew drugNov 19, 2024TABLET, EXTENDED RELEASE, ORAL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDENew drugSep 10, 2024TABLET, EXTENDED RELEASE, ORAL
LACOSAMIDENew drugSep 4, 2024TABLET, ORAL
TOLTERODINE TARTRATENew drugAug 27, 2024CAPSULE, EXTENDED RELEASE, ORAL
FAMOTIDINENew drugJan 16, 2024FOR SUSPENSION, ORAL
DOXAZOSIN MESYLATENew drugJan 10, 2024TABLET, ORAL
PRASUGREL HYDROCHLORIDENew drugAug 28, 2023TABLET, ORAL
RANOLAZINENew drugMar 16, 2023TABLET, EXTENDED RELEASE, ORAL
EXTENDED PHENYTOIN SODIUMNew drugOct 13, 2022CAPSULE, ORAL
CARBAMAZEPINENew drugAug 22, 2022TABLET, ORAL
QUETIAPINE FUMARATENew drugAug 15, 2022TABLET, EXTENDED RELEASE, ORAL
LABETALOL HYDROCHLORIDENew drugAug 8, 2022TABLET, ORAL
NEBIVOLOL HYDROCHLORIDENew drugMar 15, 2022TABLET, ORAL
DIVALPROEX SODIUMNew drugFeb 25, 2022TABLET, EXTENDED RELEASE, ORAL
ARIPIPRAZOLENew drugDec 1, 2021TABLET, ORAL
METFORMIN HYDROCHLORIDENew drugAug 11, 2021TABLET, EXTENDED RELEASE, ORAL
AMITRIPTYLINE HYDROCHLORIDENew drugMay 19, 2021TABLET, ORAL
METOLAZONENew drugMar 30, 2021TABLET, ORAL
GUANFACINE HYDROCHLORIDENew drugMar 3, 2021TABLET, ORAL
APREMILASTNew drugFeb 17, 2021TABLET, ORAL
ZONISAMIDENew drugJan 26, 2021CAPSULE, ORAL
CELECOXIBNew drugJan 12, 2021CAPSULE, ORAL

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