Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015500
Company: PHARMACIA AND UPJOHN

Products on NDA 015500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOLINASE	TOLAZAMIDE	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
TOLINASE	TOLAZAMIDE	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
TOLINASE	TOLAZAMIDE	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 015500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/1966	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/1999	SUPPL-50	Labeling		Label is not available on this site.
06/25/1987	SUPPL-48	Labeling		Label is not available on this site.
06/25/1987	SUPPL-47	Labeling		Label is not available on this site.
07/11/1986	SUPPL-46	Manufacturing (CMC)-Control		Label is not available on this site.
03/24/1986	SUPPL-45	Labeling		Label is not available on this site.
10/03/1984	SUPPL-43	Labeling		Label is not available on this site.
05/09/1983	SUPPL-42	Manufacturing (CMC)-Control		Label is not available on this site.
02/24/1978	SUPPL-40	Labeling		Label is not available on this site.
12/01/1975	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.