Clobetasol Propionate

Basic Information

Product Name

FDA Product Code

45802-925

Regulatory Information

NDC Product Code

45802-925

Application Number

ANDA075027

Marketing Category

C73584

Effective Date

November 13, 2020

Territorial Authority

USA

FDA Title

Clobetasol Propionate Gel, 0.05%

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CLOBETASOL PROPIONATE

Quantity: 0.5 mg in 1 g

Code: 779619577M

Class Code: ACTIB

CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

Code: HHT01ZNK31

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

CLOBETASOL

Code: ADN79D536H

Basic Information

Regulatory Information

Company Information

Active Ingredients

CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

WATER

PROPYLENE GLYCOL

SODIUM HYDROXIDE

Active Moieties

CLOBETASOL