Drugs@FDA: FDA-Approved Drugs
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PENTAZOCINE HYDROCHLORIDE | 325MG;EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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. |