Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENDECTIN | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | 10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
07/30/1956 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
---|---|---|---|---|---|
12/09/1982 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/07/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
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06/16/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/22/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
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10/22/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/09/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
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11/06/1979 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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07/25/1979 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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11/01/1978 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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08/01/1978 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/09/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |
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11/09/1976 | SUPPL-2 | Efficacy |
Label is not available on this site. |