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Clobetasol Propionate

CLOBETASOL PROPIONATETOPICAL SOLUTION, USP0.05%(potency expressed as clobetasol propionate)

Approved
Approval ID

8cfa527c-69c5-4722-8246-c3b4ce591a5f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-358
Application NumberANDA075205
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 25, 2006
FDA Product Classification

INGREDIENTS (5)

Clobetasol PropionateActive
Quantity: 0.5 mg in 1 mL
Code: 779619577M
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
CARBOMER HOMOPOLYMER TYPE BInactive
Code: HHT01ZNK31
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT

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Clobetasol Propionate - FDA Drug Approval Details