Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020310
Company: KRAMER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIZORAL A-D KETOCONAZOLE 1% SHAMPOO;TOPICAL Over-the-counter None 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
10/10/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20310_Nizoral.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2018 SUPPL-22 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020310s022lbl.pdf
01/03/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/05/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/17/2010 SUPPL-19 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020310s019ltr.pdf
03/08/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/2001 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/2000 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/22/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/13/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/17/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/06/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2018 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020310s022lbl.pdf

NIZORAL A-D

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SHAMPOO;TOPICAL; 1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NIZORAL A-D KETOCONAZOLE 1% SHAMPOO;TOPICAL Over-the-counter Yes 020310 KRAMER

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