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Dexcel FDA Approvals

5 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
NINTEDANIB ESYLATENew drugApr 2, 2026CAPSULE, ORAL
TOFACITINIB CITRATENew drugDec 16, 2024TABLET, EXTENDED RELEASE, ORAL
PANTOPRAZOLE SODIUMNew drugJun 16, 2023FOR SUSPENSION, DELAYED RELEASE, ORAL
OMEPRAZOLE MAGNESIUMNew drugMay 24, 2022CAPSULE, DELAYED RELEASE, ORAL
VIGABATRINNew drugSep 23, 2021TABLET, ORAL

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