Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073229
Company: CATALENT

Products on ANDA 073229

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 073229

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1991	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
12/26/2015	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/26/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/05/2014	SUPPL-11	Labeling		Label is not available on this site.
06/29/2001	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
01/18/2001	SUPPL-6	Labeling		Label is not available on this site.
01/27/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
10/14/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/15/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/15/1993	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073229

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