Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 073178
Company: ANI PHARMS INC

Products on ANDA 073178

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALPROIC ACID	VALPROIC ACID	250MG/5ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073178

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	Note
10/30/2020	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert	Label is not available on this site.
10/30/2020	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide	Label is not available on this site.
10/30/2020	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert	Label is not available on this site.
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.