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. FORMOTEROL FUMARATE inhalation solution Initial U.S. Approval: 2001
Approved
Approval ID
d3aa5d0c-020b-4447-bb02-92f284665840
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2023
Manufacturers
FDA
Rhodes Pharmaceuticals L.P.
DUNS: 831928986
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
formoterol fumarate dihydrate
PRODUCT DETAILS
NDC Product Code42858-094
Application NumberANDA215621
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJune 1, 2023
Generic Nameformoterol fumarate dihydrate
INGREDIENTS (5)
FORMOTEROL FUMARATEActive
Quantity: 20 ug in 2 mL
Code: W34SHF8J2K
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT