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Clobetasol Propionate

These highlights do not include all the information needed to use CLOBETASOL PROPIONATE SHAMPOO safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE SHAMPOO.CLOBETASOL PROPIONATE shampoo, for topical use onlyInitial U.S. Approval: 1985

Approved
Approval ID

d16ac961-bb76-4aab-9ad7-737f1958c057

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2022

Manufacturers
FDA

Akorn

DUNS: 117696873

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

NDC Product Code50383-979
Application NumberANDA209871
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 11, 2022
Generic NameClobetasol Propionate

INGREDIENTS (8)

CLOBETASOL PROPIONATEActive
Quantity: .5 mg in 1 mL
Code: 779619577M
Classification: ACTIB
COCO-BETAINEInactive
Code: 03DH2IZ3FY
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYQUATERNIUM-10 (400 MPA.S AT 2%)Inactive
Code: HB1401PQFS
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM LAURETH-3 SULFATEInactive
Code: BPV390UAP0
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
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Clobetasol Propionate - FDA Approval | MedPath