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
NDC Product Code62332-632
Application NumberANDA214396
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateDecember 22, 2023
Generic NameDesonide
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