Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073178
Company: ANI PHARMS INC
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
08/25/1992 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-23 Labeling-Package Insert

Label is not available on this site.

08/22/2006 SUPPL-21 Labeling

Label is not available on this site.

10/31/2001 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

07/05/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/2001 SUPPL-9 Labeling

Label is not available on this site.

02/26/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

12/11/2000 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/23/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/02/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/02/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/13/1995 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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