Proventil HFA
Approved
Approval ID
cb4f1002-9372-4fac-aea3-99142f93dd37
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6051
Application NumberNDA020503
Product Classification
M
Marketing Category
C73594
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 30, 2009
FDA Product Classification
INGREDIENTS (3)
ALBUTEROL SULFATEActive
Quantity: 108 ug in 1 1
Code: 021SEF3731
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT