Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078919
Company: ZYDUS PHARMS USA INC

Products on ANDA 078919

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078919

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2009	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
07/06/2020	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/06/2020	SUPPL-24	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/09/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
11/30/2015	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/11/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/11/2015	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/11/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/08/2014	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/08/2014	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/11/2014	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/11/2014	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/11/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/02/2010	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/07/2010	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 078919

DIVALPROEX SODIUM

CAPSULE, DELAYED REL PELLETS;ORAL; EQ 125MG VALPROIC ACID
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEPAKOTE	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	Yes	AB	019680	ABBVIE
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	213181	AJANTA PHARMA LTD
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	218793	ALEMBIC
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	078979	DR REDDYS LABS LTD
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	217358	MANKIND PHARMA
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	078919	ZYDUS PHARMS USA INC