Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091037
Company: SUN PHARM INDS LTD

Products on ANDA 091037

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALPROIC ACID	VALPROIC ACID	250MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091037

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2013	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
12/15/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/15/2014	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091037

VALPROIC ACID

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VALPROIC ACID	VALPROIC ACID	250MG	CAPSULE;ORAL	Prescription	No	AB	073484	BIONPHARMA
VALPROIC ACID	VALPROIC ACID	250MG	CAPSULE;ORAL	Prescription	No	AB	073229	CATALENT
VALPROIC ACID	VALPROIC ACID	250MG	CAPSULE;ORAL	Prescription	No	AB	091037	SUN PHARM INDS LTD