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Desonide

Desonide Cream, 0.05%For Dermatologic Use OnlyNot For Ophthalmic UseRx Only

Approved
Approval ID

99955d05-1198-4cd6-b2b4-9c328e48c0b2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 11, 2025

Manufacturers
FDA

Alembic Pharmaceuticals Limited

DUNS: 650574663

Products 1

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

Desonide

PRODUCT DETAILS

NDC Product Code46708-632
Application NumberANDA214396
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateApril 11, 2025
Generic NameDesonide

INGREDIENTS (12)

DESONIDEActive
Quantity: 0.5 mg in 1 g
Code: J280872D1O
Classification: ACTIB
ALUMINUM SULFATEInactive
Code: 34S289N54E
Classification: IACT
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
ICODEXTRINInactive
Code: 2NX48Z0A9G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT

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Desonide - FDA Drug Approval Details