Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073484
Company: BIONPHARMA INC
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
06/29/1993 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
11/30/2015 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

11/30/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

11/30/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

11/30/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/10/2014 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

01/25/2011 SUPPL-20 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert

Label is not available on this site.

01/12/2010 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

04/01/2008 SUPPL-17 Labeling

Label is not available on this site.

09/23/2007 SUPPL-14 Labeling

Label is not available on this site.

12/17/2006 SUPPL-13 Labeling

Label is not available on this site.

10/08/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/02/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/02/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/02/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/30/1996 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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