Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016891
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TALWIN COMPOUND | ASPIRIN; PENTAZOCINE HYDROCHLORIDE | 325MG;EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 11/12/1975 | 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 |
|---|---|---|---|---|---|
| 11/29/1995 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/25/1996 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/03/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 03/17/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/05/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/05/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/09/1982 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 12/01/1981 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/02/1981 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 11/05/1980 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 01/05/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/30/1979 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1979 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/08/1979 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/09/1977 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/08/1979 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/13/1977 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 02/23/1976 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |