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Desonide

Desonide Cream, 0.05%

Approved
Approval ID

0665dd04-1d0b-45bf-90e4-c6e0bd90956d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 19, 2023

Manufacturers
FDA

NORTHSTAR RX LLC

DUNS: 830546433

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 Code16714-729
Application NumberANDA073548
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 19, 2023
FDA Product Classification

INGREDIENTS (11)

ALUMINUM SUBACETATEInactive
Code: FGL8577C9S
Classification: IACT
DesonideActive
Quantity: 0.5 mg in 1 g
Code: J280872D1O
Classification: ACTIB
SODIUM CETOSTEARYL SULFATEInactive
Code: 7ZBS06BH4B
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT

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Desonide - FDA Drug Approval Details