Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017669
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENUATE DIETHYLPROPION HYDROCHLORIDE 75MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
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 5 - New Formulation or New Manufacturer 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-9 Labeling

Label is not available on this site.

11/02/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1978 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/28/1976 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/28/1976 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2007 SUPPL-2 Labeling

Label is not available on this site.

06/19/1975 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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