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FDA Approval

VENTOLINHFA

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 1, 2009
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Salbutamol(108 ug in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Rebel Distributors Corp.

Rebel Distributors Corp.

118802834

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VENTOLINHFA HFA

Product Details

NDC Product Code
21695-423
Application Number
NDA020983
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
September 1, 2009
Code: 021SEF3731Class: ACTIBQuantity: 108 ug in 1 1
NORFLURANEInactive
Code: DH9E53K1Y8Class: IACT
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