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MOMETASONE FUROATE

Approved
Approval ID

c337bce8-27e9-48fd-85fa-381d0242a36a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 31, 2011

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

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 Code16590-993
Application NumberANDA077447
Product Classification
M
Marketing Category
C73584
G
Generic Name
MOMETASONE FUROATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 31, 2011
FDA Product Classification

INGREDIENTS (9)

MOMETASONE FUROATEActive
Quantity: 1 mg in 1 g
Code: 04201GDN4R
Classification: ACTIB
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
PROPYLENE GLYCOL MONOSTEARATEInactive
Code: F76354LMGR
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT

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MOMETASONE FUROATE - FDA Drug Approval Details