Mometasone Furoate
These highlights do not include all the information needed to use MOMETASONE FUROATE CREAM safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM. MOMETASONE FUROATE cream, for topical use Initial U.S. Approval: 1987
Approved
Approval ID
831f7694-8153-4a79-a453-48020b26f035
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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
NDC Product Code68788-8548
Application NumberANDA076679
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateNovember 14, 2023
Generic NameMometasone Furoate
INGREDIENTS (11)
aluminum starch octenylsuccinateInactive
Code: I9PJ0O6294
Classification: IACT
polyoxyl 20 cetostearyl etherInactive
Code: YRC528SWUY
Classification: IACT
Mometasone FuroateActive
Quantity: 1 mg in 1 g
Code: 04201GDN4R
Classification: ACTIB
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
propylene glycol monostearateInactive
Code: MZM1I680W0
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT