Desonide
Desonide Lotion, 0.05% Rx only For Dermatologic Use Only.Not for Ophthalmic Use.
Approved
Approval ID
90f27c9b-5c9e-4152-9ddf-659231ca993a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 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 Code62332-550
Application NumberANDA213632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (14)
DESONIDEActive
Quantity: 0.5 mg in 1 mL
Code: J280872D1O
Classification: ACTIB
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT