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Hearing Opportunity for NDA Withdrawal Proposal

06/28/2007

Federal Register Notice: FDA is announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of six NDAs from multiple sponsors who have repeatedly failed to file required annual reports for these applications. The NDAs are: Menley & James Laboratories Benzedrex Nasal Spray, Pfizer’s Synthetic Vitamin A, Barnes Hind’s Isoniazid tablets, NDK Co.’s NDK Fluoride Dentifrice, Glennwood’s Paskalium, and Chesebrough Ponds’ Extra Strength Aim. To view this notice, click here.

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