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): 209286
Company: LUPIN

Products on ANDA 209286

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	Prescription	AB	No	No
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209286

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2026	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
06/11/2026	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/11/2026	SUPPL-17	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/10/2024	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/10/2023	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/16/2022	SUPPL-6	Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/16/2022	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/16/2022	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 209286

DIVALPROEX SODIUM

TABLET, EXTENDED RELEASE;ORAL; EQ 250MG VALPROIC ACID
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEPAKOTE ER	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021168	ABBVIE
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203730	AMNEAL PHARMS
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215527	ANNORA PHARMA
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202419	AUROBINDO PHARMA LTD
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090161	DR REDDYS LABS LTD
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209286	LUPIN
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077567	MYLAN
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078705	SCIEGEN PHARMS
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214643	UNICHEM
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078239	ZYDUS PHARMS USA INC

TABLET, EXTENDED RELEASE;ORAL; EQ 500MG VALPROIC ACID
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEPAKOTE ER	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021168	ABBVIE
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203730	AMNEAL PHARMS
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	215527	ANNORA PHARMA
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202419	AUROBINDO PHARMA LTD
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209286	LUPIN
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077567	MYLAN
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090070	REDDYS
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078705	SCIEGEN PHARMS
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214643	UNICHEM
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078239	ZYDUS PHARMS USA INC

Top