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Sawai USA FDA Approvals

2 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
MIRABEGRONNew drugMay 6, 2025TABLET, EXTENDED RELEASE, ORAL
DIMETHYL FUMARATENew drugDec 21, 2021CAPSULE, DELAYED RELEASE, ORAL

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