Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NIZORAL | KETOCONAZOLE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/12/1981 | 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 |
|---|---|---|---|---|---|
| 02/25/2014 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018533Orig1s041ltr.pdf | |
| 07/25/2013 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018533s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018533Orig1s040ltr.pdf | |
| 08/13/2002 | SUPPL-39 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/01/2002 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1999 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/13/1999 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1998 | SUPPL-35 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1998 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/17/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1996 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/08/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1996 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/15/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1995 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1995 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/20/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/13/1992 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/15/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/14/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1988 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/19/1985 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/09/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1984 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1983 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/23/1983 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/29/1981 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/25/2014 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018533s041lbl.pdf | |
| 07/25/2013 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018533s040lbl.pdf |