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Mometasone Furoate

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1987

Approved
Approval ID

c9d7c8b2-de3c-44b1-b22d-1b0c10c46fe9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2018

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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 Code50090-2179
Application NumberANDA078541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mometasone Furoate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 19, 2015
FDA Product Classification

INGREDIENTS (11)

HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
PROPYLENE GLYCOL MONOSTEARATEInactive
Code: MZM1I680W0
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
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
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Mometasone Furoate - FDA Drug Approval Details