Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072274
Company: ANI PHARMS

Products on ANDA 072274

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	EQ 600MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072274

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/1988	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
11/21/2024	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
02/18/2016	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/08/2002	SUPPL-14	Labeling		Label is not available on this site.
02/26/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/02/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/18/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/13/1994	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/22/1991	SUPPL-8	Labeling		Label is not available on this site.
07/29/1991	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/04/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/04/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.