Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019927
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIZORAL KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription AB Yes Yes
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

NIZORAL

SHAMPOO;TOPICAL; 2%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETOCONAZOLE KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription No AB 076419 PERRIGO ISRAEL
KETOCONAZOLE KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription No AB 076942 TOLMAR
NIZORAL KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription Yes AB 019927 JANSSEN PHARMS

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