Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.

21 C.F.R. § 314.160
in effectEffective: 2024-07-01
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Upon the Food and Drug Administration's own initiative or upon request of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the Federal Register announcing the approval.

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