Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016099
Company: WYETH AYERST

Products on NDA 016099

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROMID-S	CLOFIBRATE	500MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016099

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/1967	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
07/07/1998	SUPPL-61	Manufacturing (CMC)-Control		Label is not available on this site.
04/08/1996	SUPPL-60	Labeling		Label is not available on this site.
03/24/1995	SUPPL-59	Labeling		Label is not available on this site.
04/19/1994	SUPPL-58	Labeling		Label is not available on this site.
07/27/1994	SUPPL-57	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/1991	SUPPL-56	Labeling		Label is not available on this site.
03/11/1994	SUPPL-55	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/26/1989	SUPPL-54	Manufacturing (CMC)		Label is not available on this site.
07/15/1987	SUPPL-53	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/25/1990	SUPPL-52	Labeling		Label is not available on this site.
11/19/1986	SUPPL-51	Manufacturing (CMC)-Control		Label is not available on this site.
09/01/1983	SUPPL-46	Unspecified		Label is not available on this site.
08/23/1978	SUPPL-29	Labeling		Label is not available on this site.