Drugs@FDA: FDA-Approved Drugs
Company: UPSHER SMITH LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLUTETHIMIDE | GLUTETHIMIDE | 500MG | 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 |
---|---|---|---|---|---|---|---|
10/28/1976 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/19/2000 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/08/1991 | SUPPL-52 | Labeling |
Label is not available on this site. |
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01/15/1987 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/30/1986 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/19/1984 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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06/01/1984 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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01/23/1984 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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01/23/1984 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/1982 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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01/27/1983 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1982 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1982 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/30/1982 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1982 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |