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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020259
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPRON ATOVAQUONE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/25/1992 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

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