Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017669
Company: SANOFI AVENTIS US
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. |