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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203730
Company: AMNEAL PHARMS

Products on ANDA 203730

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203730

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203730Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/08/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/08/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/08/2020	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/08/2020	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 203730

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 LTD
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 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	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

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