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
419bc85d-8e24-478b-921e-babfb73e79f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2020
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-4061
Application NumberANDA091141
Product Classification
M
Marketing Category
C73584
G
Generic Name
Formoterol fumarate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 31, 2020
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FORMOTEROL FUMARATEActive
Quantity: 20 ug in 2 mL
Code: W34SHF8J2K
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT