Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: J&J's Nizoral A-D

This article was originally published in The Tan Sheet

Executive Summary

J&J's Nizoral A-D: Ketoconazole dandruff shampoo receives second "approvable" designation from FDA May 15. The product was first deemed "approvable" on March 13, 1996 ("The Tan Sheet" June 3, 1996, p. 1). FDA's Dermatologic Drugs and Nonprescription Drugs Advisory Committees unanimously recommended Nizoral A-D for OTC marketing as a dandruff treatment in February 1994 ("The Tan Sheet" Feb. 21, 1994, pp. 1-5). J&J filed the NDA switch application, #020310, in December 1992. Prescription Nizoral with 2% ketoconazole has been available in the U.S. since 1990...
Advertisement
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS087126

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel