Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TALWIN 50 | PENTAZOCINE HYDROCHLORIDE | EQ 50MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 02/03/1969 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/19/1982 | SUPPL-51 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/02/1981 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 01/09/1981 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/02/1980 | SUPPL-45 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/19/1980 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/05/1979 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 07/23/1979 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 05/31/1979 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 04/30/1979 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 04/11/1979 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 11/06/1978 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/28/1978 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/28/1977 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/1977 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 05/11/1977 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/16/1976 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 10/31/1975 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 07/30/1975 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/30/1975 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/03/1975 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/26/1974 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 12/09/1974 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 11/08/1974 | SUPPL-22 | Labeling |
Label is not available on this site. |