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Clodan

These highlights do not include all the information needed to use Clodan (clobetasol propionate) Shampoo, 0.05% safely and effectively. See full prescribing information for Clodan (clobetasol propionate) Shampoo, 0.05%. Clodan (CLOBETASOL PROPIONATE) shampoo, for topical use Initial U.S. Approval: 1985

Approved
Approval ID

b5d32546-65dc-4b0c-826e-ddbc2a50b152

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2023

Manufacturers
FDA

Medimetriks Pharmaceuticals

DUNS: 019903816

Products 1

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

clobetasol propionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43538-950
Application NumberANDA090974
Product Classification
M
Marketing Category
C73584
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 12, 2022
FDA Product Classification

INGREDIENTS (7)

clobetasol propionateActive
Quantity: 0.5 mg in 1 mL
Code: 779619577M
Classification: ACTIB
alcoholInactive
Code: 3K9958V90M
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
coco-betaineInactive
Code: 03DH2IZ3FY
Classification: IACT
sodium laureth-3 sulfateInactive
Code: BPV390UAP0
Classification: IACT
POLYQUATERNIUM-10 (400 MPA.S AT 2%)Inactive
Code: HB1401PQFS
Classification: IACT

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Clodan - FDA Drug Approval Details