Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090062
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
03/17/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/08/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/20/2010 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

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