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ShawnP123

03/22/17 4:48 PM

#6987 RE: BooDog #6981

BooDog- There's a difference between qualification for a Generic and an ANDA. A generic could be new such as first time approval for an existing non generic.

When Glaxco came out with their OTC, it didn't take 3 years. Other companies have had their ANDA fluticasone propionate approved in 2-2.5 years. There is a difference between Generic and an ANDA.

I submitted the info from the FDA on this.