Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076941
Company: TEVA
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
07/29/2008 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076941s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076941s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/20/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

02/20/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

02/20/2016 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/20/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/20/2016 SUPPL-12 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/13/2014 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/13/2014 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/13/2014 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/13/2014 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/13/2014 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/20/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/29/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/076941s000lbl.pdf

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