Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080142
Company: ANI PHARMS

Products on ANDA 080142

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULFISOXAZOLE	SULFISOXAZOLE	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080142

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/1974	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
07/29/2002	SUPPL-72	Manufacturing (CMC)-Facility		Label is not available on this site.
03/12/2002	SUPPL-71	Manufacturing (CMC)-Facility		Label is not available on this site.
01/28/2000	SUPPL-69	Manufacturing (CMC)-Facility		Label is not available on this site.
11/23/1999	SUPPL-68	Manufacturing (CMC)-Facility		Label is not available on this site.
11/05/1999	SUPPL-67	Manufacturing (CMC)-Facility		Label is not available on this site.
11/05/1999	SUPPL-66	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
11/05/1999	SUPPL-65	Manufacturing (CMC)-Control		Label is not available on this site.
11/05/1999	SUPPL-64	Manufacturing (CMC)-Facility		Label is not available on this site.
08/20/1999	SUPPL-63	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-62	Manufacturing (CMC)		Label is not available on this site.
05/30/1997	SUPPL-61	Manufacturing (CMC)		Label is not available on this site.
04/17/1996	SUPPL-60	Labeling		Label is not available on this site.
01/05/1993	SUPPL-59	Manufacturing (CMC)		Label is not available on this site.
08/14/1992	SUPPL-58	Manufacturing (CMC)		Label is not available on this site.