Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070868
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription AA 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
07/01/1986 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
01/06/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

12/15/2006 SUPPL-14 Labeling

Label is not available on this site.

03/10/2004 SUPPL-12 Labeling

Label is not available on this site.

03/21/2003 SUPPL-10 Labeling

Label is not available on this site.

05/24/2002 SUPPL-9 Labeling

Label is not available on this site.

05/04/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/04/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/24/1993 SUPPL-6 Labeling

Label is not available on this site.

01/11/1989 SUPPL-5 Labeling

Label is not available on this site.

06/15/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/10/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

VALPROIC ACID

SYRUP;ORAL; 250MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription No AA 073178 ANI PHARMS INC
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription No AA 090517 ECI PHARMS LLC
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription No AA 074060 HIGH TECH PHARMA
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription No AA 077960 LANNETT CO INC
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription No AA 075379 PHARM ASSOC
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription No AA 075782 VISTAPHARM
VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP;ORAL Prescription No AA 070868 WOCKHARDT BIO AG

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