Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Kindeva Drug Delivery L.P.
117492677
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Kindeva Drug Delivery L.P.
Sandoz
Kindeva Drug Delivery L.P.
128688199
Kindeva Drug Delivery Limited
Sandoz
Kindeva Drug Delivery L.P.
225650929
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Proventil HFA
Product Details
NDC Product Code
66758-959Application Number
NDA020503Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
June 14, 2023ALCOHOLInactive
Code: 3K9958V90MClass: IACT
NORFLURANEInactive
Code: DH9E53K1Y8Class: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CPClass: IACT
SalbutamolActive
Code: 021SEF3731Class: ACTIMQuantity: 108 ug in 1 1