Formoterol fumarate
These highlights do not include all the information needed to use FORMOTEROL FUMARATE INHALATION SOLUTION safely and effectively. See full prescribing information for FORMOTEROL FUMARATE INHALATION SOLUTION. FUMARATE inhalation solution, for respiratory use Initial U.S. Approval: 2001
Approved
Approval ID
9786f3e2-4265-4246-9999-f73cd6b33fc8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Formoterol fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8813
Application NumberANDA091141
Product Classification
M
Marketing Category
C73584
G
Generic Name
Formoterol fumarate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 13, 2021
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
FORMOTEROL FUMARATEActive
Quantity: 20 ug in 2 mL
Code: W34SHF8J2K
Classification: ACTIB