If it is a supplement requiring the review of clinical data but it is not an effectiveness supplement, describe the change or claim that is supported by the clinical data:

 

            d) Did the applicant request exclusivity?

 

                                                                                    YES /___/        NO /_X_/

 

                If the answer to (d) is “yes,” how many years of exclusivity did the applicant request?

 

e)      Has pediatric exclusivity been granted for this Active Moiety?

 

                                                                        YES /___/        NO /_X_/

 

IF YOU HAVE ANSWERED “NO” TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO THE SIGNATURE BLOCKS ON Page 9.

 

2.       Has a product with the same active ingredient(s), dosage form, strength, route of administration, and dosing schedule previously been approved by FDA for the same use?  (RX to OTC) Switches should be answered No -  Please indicate as such).

 

                                                                                    YES /__/          NO /_X_/

 

      If yes, NDA # __________________    Drug Name

 

 

IF THE ANSWER TO QUESTION 2 IS “YES,” GO DIRECTLY TO THE SIGNATURE BLOCKS ON Page 9.

 

3.       Is this drug product or indication a DESI upgrade?

 

                                                                                    YES /___/        NO /_X_/

 

 

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