Drugs@FDA: FDA-Approved Drugs
Company: MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COLBENEMID | COLCHICINE; PROBENECID | 0.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
07/27/1961 | 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 |
---|---|---|---|---|---|
08/18/1994 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/20/1994 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/30/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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05/12/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
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05/12/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
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05/12/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
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03/02/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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07/23/1985 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/24/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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05/10/1979 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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08/21/1981 | SUPPL-14 | Labeling |
Label is not available on this site. |
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06/01/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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05/30/1979 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |