Desonide
Desonide Cream, 0.05%For Dermatologic Use OnlyNot For Ophthalmic UseRx Only
Approved
Approval ID
c3420815-e9d8-4c19-b601-b918b0aa1f84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-632
Application NumberANDA214396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (12)
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
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
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT