Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017668
Company: SANOFI AVENTIS US

Products on NDA 017668

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TENUATE	DIETHYLPROPION HYDROCHLORIDE	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017668

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/1975	ORIG-1	Approval	Type 3 - New Dosage Form	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
05/18/1981	SUPPL-10	Labeling		Label is not available on this site.
05/27/1980	SUPPL-9	Labeling		Label is not available on this site.
05/12/1980	SUPPL-8	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/02/1979	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/27/1978	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/24/1976	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/24/1976	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/10/1976	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/07/2007	SUPPL-1	Labeling		Label is not available on this site.