Asmanex
These highlights do not include all the information needed to use ASMANEX TWISTHALER safely and effectively. See full prescribing information for ASMANEX TWISTHALER. ASMANEX TWISTHALER 110 mcg, 220 mcg (mometasone furoate inhalation powder)Initial U.S. Approval: 1987
Approved
Approval ID
ba17a773-7f7a-4cc5-9297-359decedfed0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2010
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.
Mometasone Furoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5547
Application NumberNDA021067
Product Classification
M
Marketing Category
C73594
G
Generic Name
Mometasone Furoate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 19, 2010
FDA Product Classification
INGREDIENTS (2)
MOMETASONE FUROATEActive
Quantity: 220 ug in 1 1
Code: 04201GDN4R
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT