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Desoximetasone

DESOXIMETASONE CREAM USP, 0.25%

Approved
Approval ID

4ad6c159-4daa-4a33-8db6-351b5263323d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 9, 2023

Manufacturers
FDA

Padagis Israel Pharmaceuticals Ltd

DUNS: 600093611

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Desoximetasone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code45802-495
Application NumberANDA076510
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desoximetasone
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 11, 2017
FDA Product Classification

INGREDIENTS (10)

CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
ALUMINUM MONOSTEARATEInactive
Code: P9BC99461E
Classification: IACT
DesoximetasoneActive
Quantity: 2.5 mg in 1 g
Code: 4E07GXB7AU
Classification: ACTIB
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Desoximetasone - FDA Drug Approval Details