An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076941
Company: TEVA

Products on ANDA 076941

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076941

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
10/13/2020	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/13/2020	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/13/2020	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/13/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
10/13/2020	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/13/2020	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2014	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		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-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2014	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2014	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/20/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 076941

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

Top