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Zydus FDA Approvals

8 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
DIROXIMEL FUMARATENew drugNov 12, 2025CAPSULE, DELAYED RELEASE, ORAL
AMANTADINENew drugAug 26, 2024CAPSULE, EXTENDED RELEASE, ORAL
PIMAVANSERINNew drugJan 16, 2024TABLET, ORAL
PIMAVANSERINNew drugJan 16, 2024CAPSULE, ORAL
OXCARBAZEPINENew drugJul 3, 2023TABLET, ORAL
VARENICLINE TARTRATENew drugJun 12, 2023TABLET, ORAL
TOPIRAMATENew drugNov 28, 2022CAPSULE, EXTENDED RELEASE, ORAL
CARIPRAZINE HYDROCHLORIDENew drugSep 9, 2022CAPSULE, ORAL

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