Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NIZORAL | KETOCONAZOLE | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/31/1985 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 04/02/2002 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/08/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/30/1999 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/04/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/1998 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/26/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/09/1998 | 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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| 10/08/1996 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/09/1996 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/16/1996 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/17/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/17/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1995 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/02/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/07/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1993 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
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| 10/12/1990 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/14/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/01/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/28/1987 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 07/28/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/17/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |