Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMS
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NIZORAL | KETOCONAZOLE | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SHAMPOO;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/31/1990 | 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 |
---|---|---|---|---|---|
01/08/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/05/2013 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/29/2013 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019927s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019927Orig1s032ltr.pdf | |
12/04/2012 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019927s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019927Orig1s031ltr.pdf | |
08/07/2009 | SUPPL-28 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019927s028lbl.pdf | |
10/02/2002 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/06/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/28/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/01/1999 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/26/1998 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/26/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/09/1998 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/10/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
07/09/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/30/1997 | SUPPL-12 | Efficacy-New Indication |
Label is not available on this site. |
||
04/25/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
11/02/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/08/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/26/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/07/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/02/1993 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/11/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/06/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
10/05/1990 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/29/2013 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019927s032lbl.pdf | |
12/04/2012 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019927s031lbl.pdf | |
08/07/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019927s028lbl.pdf |