Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078790
Company: LUPIN

Products on ANDA 078790

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 078790

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			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078790s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2026	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/28/2026	SUPPL-31	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/28/2026	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
08/13/2024	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/31/2023	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/31/2023	SUPPL-27	Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/31/2023	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/31/2023	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
01/14/2020	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/14/2020	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/14/2020	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/14/2020	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
01/14/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
01/14/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
01/14/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
01/14/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/14/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
01/14/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/08/2014	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/08/2014	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/08/2014	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/20/2010	SUPPL-2	Labeling		Label is not available on this site.