NDA 20-358

Page 3

 

Please submit sixteen copies of the printed labeling, ten of which are individually mounted on heavy weight paper or similar material.

 

In addition, please submit three copies of the introductory promotional material that you propose to use for this product.  All proposed materials should be submitted in draft or mock-up form, not final print.  Please submit one copy to this Division and two copies of both the promotional material and the package insert directly to:

 

                Food and Drug Administration

                Division of Drug Marketing, Advertising and Communications.

                HFD-40

                5600 Fishers Lane

                Rockville, Maryland 20857

 

Within 10 days after the date of this letter, you are required to amend the application, notify us if your intent to file an amendment, or follow one of your other option under 21 CFR 314.110.  In the absence of such action FDA may take action to withdraw the application.

 

Should you have any questions, please contact:

 

                Paul David, R.PH.

                Regulatory Management Officer

                Telephone (301) 594-2777

 

                                                                                Sincerely yours,

                                                               

                                                                                (signature) (3/11/96)

                                                                                Robert Temple, M.D.

                                                                                Director

                                                                                Office of Drug Evaluation 1

                                                                                Center for Drug Evaluation and Research

 

ATTACHMENT

 

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