Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008565
Company: WYETH AYERST

Products on NDA 008565

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOSULFIL	SULFAMETHIZOLE	250MG	TABLET;ORAL	Discontinued	None	No	No
THIOSULFIL	SULFAMETHIZOLE	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008565

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/1953	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/17/1988	SUPPL-21	Labeling		Label is not available on this site.
12/30/1987	SUPPL-20	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/17/1980	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/26/1980	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/16/1979	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/22/1978	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
01/31/1978	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
06/01/1978	SUPPL-9	Labeling		Label is not available on this site.
07/25/1977	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/23/1976	SUPPL-7	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/20/1976	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/04/1974	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
11/04/1974	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/26/1975	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.