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desonide

DESONIDE OINTMENT, 0.05%

Approved
Approval ID

4373825a-7ecc-4e12-8ee9-acb3304e1418

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 1, 2018

Manufacturers
FDA

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

DUNS: 043838424

Products 1

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

desonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0168-0309
Application NumberANDA075751
Product Classification
M
Marketing Category
C73584
G
Generic Name
desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 24, 2016
FDA Product Classification

INGREDIENTS (2)

DESONIDEActive
Quantity: 0.5 mg in 1 g
Code: J280872D1O
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT

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desonide - FDA Drug Approval Details