Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090070
Company: REDDYS

Products on ANDA 090070

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 090070

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2012	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
06/08/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/08/2023	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/08/2023	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/20/2020	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/20/2020	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/20/2020	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/20/2020	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/20/2020	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/20/2020	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/20/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/20/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/20/2014	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/20/2014	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090070

DIVALPROEX SODIUM

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 LTD
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	214643	UNICHEM
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078705	WOCKHARDT
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078239	ZYDUS PHARMS USA INC