Re: Pennymonster1; It's the original Fluticare ANDA, (Abbrievated, New, Drug, Application) for OTC sales world-wide, not just USA sales.
Since, 2015 Dr.Damaj has been saying FDA approval is imminent, but it never happened and he even issued 25million shares to Novalere prematurely because of the ANDA, because Novalere had the agreement with the original manufacturing facility, either Hi-Tech or Akorn, I remember which one.
As a result, Dr.D, had to work out a lower-profit, back up plan with Westward, for Fluticare OTC, USA only sales.
GSK got FDA OTC, world-wide sales approval for Flonase in a few months after filing.
