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DESONATE

These highlights do not include all the information needed to use DESONATE Gel safely and effectively. See full prescribing information for DESONATE  Gel.DESONATE (desonide) Gel for topical use only Initial U.S. Approval: 1972

Approved
Approval ID

4ae18cfa-0451-466d-80cd-73f6748405b6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 8, 2010

Manufacturers
FDA

Intendis Inc.

DUNS: 363706040

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 Code10922-828
Application NumberNDA021844
Product Classification
M
Marketing Category
C73594
G
Generic Name
desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 19, 2009
FDA Product Classification

INGREDIENTS (8)

DESONIDEActive
Quantity: 0.5 mg in 1 g
Code: J280872D1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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DESONATE - FDA Drug Approval Details