Proairhfa aerosol, metered

Ingredients and appearance - Product information

Proairhfa aerosol, metered- Albuterol sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68788-9900
Route of Administration Respiratory (inhalation)

Active Ingredient/Active Moiety

Ingredient Name Strength
Albuterol sulfate ( UNII: 021SEF3731)( Albuterol - UNII: QF8SVZ843E ) 90 ugin 1

Inactive Ingredients

Ingredient Name Code
Norflurane ( UNII: DH9E53K1Y8)
Alcohol ( UNII: 3K9958V90M)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021457 USA

Labeler - Preferred Pharmaceuticals, Inc( 791119022)

Establishment

Name ID/FEI Business Operations
Preferred Pharmaceuticals, Inc 791119022 RELABEL( 68788-9900)
This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the PROAIR HFA Inhalation Aerosol group and more frequently in the PROAIR HFA Inhalation Aerosol group than in the placebo HFA Inhalation Aerosol group.