Drugs@FDA: FDA Approved Drug Products

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

VALPROIC ACID

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPAKENE VALPROIC ACID 250MG CAPSULE;ORAL Prescription Yes AB 018081 ABBVIE
VALPROIC ACID VALPROIC ACID 250MG CAPSULE;ORAL Prescription No AB 073484 BIONPHARMA INC
VALPROIC ACID VALPROIC ACID 250MG CAPSULE;ORAL Prescription No AB 073229 CATALENT
VALPROIC ACID VALPROIC ACID 250MG CAPSULE;ORAL Prescription No AB 207611 NOVELGENIX THERAPS
VALPROIC ACID VALPROIC ACID 250MG CAPSULE;ORAL Prescription No AB 091037 SUN PHARM INDS LTD

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