Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017668
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 | 25MG | TABLET;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 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. |
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05/27/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/12/1980 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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11/02/1979 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/27/1978 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/24/1976 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/24/1976 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/10/1976 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/07/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |