Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRANCOPAL | CHLORMEZANONE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
TRANCOPAL | CHLORMEZANONE | 200MG | 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 |
---|---|---|---|---|---|---|---|
05/20/1960 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
02/15/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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06/08/1993 | SUPPL-29 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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09/30/1993 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/25/1990 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
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05/25/1993 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/20/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
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10/29/1985 | SUPPL-21 | Labeling |
Label is not available on this site. |
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01/28/1987 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/08/1991 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/22/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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03/13/2009 | SUPPL-17 | Labeling |
Label is not available on this site. |
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08/29/1984 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/24/1984 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/10/1981 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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12/17/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/05/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/04/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/14/1976 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |