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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078445
Company: ANCHEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 250MG VALPROIC ACID TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
DIVALPROEX SODIUM DIVALPROEX SODIUM EQ 500MG VALPROIC ACID TABLET, EXTENDED 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
02/26/2009 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
02/28/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
02/28/2016 SUPPL-15 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
02/28/2016 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
10/26/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
10/26/2014 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/26/2014 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/26/2014 SUPPL-5 Labeling

Label is not available on this site.
08/04/2009 SUPPL-4 Labeling

Label is not available on this site.
08/04/2009 SUPPL-3

Label is not available on this site.
08/04/2009 SUPPL-2

Label is not available on this site.
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