Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018533
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NIZORAL KETOCONAZOLE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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

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