ALBUTEROL SULFATE
1171 ALBUTEROL (PROAIR)
Approved
Approval ID
874bcb9b-3b51-1375-e053-2a95a90ad559
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2019
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ALBUTEROL SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76519-1171
Application NumberNDA021457
Product Classification
M
Marketing Category
C73594
G
Generic Name
ALBUTEROL SULFATE
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 24, 2019
FDA Product Classification
INGREDIENTS (1)
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 g
Code: 021SEF3731
Classification: ACTIM