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FDA Approval

AIRSUPRA

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

FDA Approval Summary

Company
Effective Date
January 10, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Salbutamol(90 ug in 1 1)
Budesonide(80 ug in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

AstraZeneca PLC

230790719

Products1

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

AIRSUPRA

Product Details

NDC Product Code
0310-9080
Application Number
NDA214070
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 10, 2023
NORFLURANEInactive
Code: DH9E53K1Y8Class: IACT
Code: 021SEF3731Class: ACTIMQuantity: 90 ug in 1 1
Code: Q3OKS62Q6XClass: ACTIBQuantity: 80 ug in 1 1
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINEInactive
Code: 043IPI2M0KClass: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACT
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