Drugs@FDA: FDA-Approved Drugs
Company: SCHERING PLOUGH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOTRIMIN | CLOTRIMAZOLE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 02/03/1975 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/08/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/07/2000 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/28/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/18/1998 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-21 | Efficacy-New Indication |
Label is not available on this site. |
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| 06/23/1992 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/25/1991 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-18 | Efficacy-New Indication |
Label is not available on this site. |
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| 04/06/1989 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/27/1989 | SUPPL-15 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
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| 06/18/1987 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/20/1986 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/20/1985 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/03/1984 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 08/06/1984 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/03/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 08/05/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/09/1980 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/18/1978 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/13/1977 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/09/1977 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/13/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/29/1976 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 04/22/1975 | SUPPL-1 | Labeling |
Label is not available on this site. |