Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087665
Company: BARR

Products on ANDA 087665

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULFINPYRAZONE	SULFINPYRAZONE	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087665

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/1982	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
01/02/2003	SUPPL-22	Labeling		Label is not available on this site.
12/21/1999	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
08/27/1999	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/20/1999	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/12/1991	SUPPL-12	Labeling		Label is not available on this site.
03/08/1991	SUPPL-11	Labeling		Label is not available on this site.
07/14/1989	SUPPL-10	Labeling		Label is not available on this site.
03/20/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/22/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/22/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.