Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077254
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 125MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Discontinued None No No
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Discontinued None No No
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, DELAYED RELEASE;ORAL Discontinued None No 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
06/09/2006 ORIG-1 Tentative Approval

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