After exposure to extreme environmental temperatures, an increase in propellant-leak rate was observed with Proventil HFA and Ventolin HFA MDIs, but little to no change was found in particle size ...

It is undisputed that the Inhaler Patents do not claim the active ingredient, albuterol sulfate, in the reference ProAir® HFA Inhalation Aerosol product. Amneal filed an Abbreviated New Drug ...