Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Teva Respiratory, LLC
176697907
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
IVAX Pharmaceuticals Ireland
H.J. Harkins Company, Inc.
Teva Respiratory, LLC
985123517
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROAIRHFA HFA
Product Details
NDC Product Code
52959-978Application Number
NDA021457Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
November 4, 2011NORFLURANEInactive
Code: DH9E53K1Y8Class: IACT
SalbutamolActive
Code: 021SEF3731Class: ACTIMQuantity: 90 ug in 1 1
ALCOHOLInactive
Code: 3K9958V90MClass: IACT