Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019084
Company: JANSSEN PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIZORAL KETOCONAZOLE 2% 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.

03/08/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1999 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1998 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/26/1998 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1998 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-22 Labeling

Label is not available on this site.

10/08/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1996 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

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.

11/17/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/02/1995 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/02/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/02/1995 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/28/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/28/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/27/1993 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

10/12/1990 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/31/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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.

11/01/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/28/1987 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/28/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/17/1988 SUPPL-1 Labeling

Label is not available on this site.

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