Cabtreo

Cabtreo

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Bausch Health US LLC

DUNS: 831922468

Effective Date

November 7, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Clindamycin(12 mg in 1 g)

Benzoyl peroxide(31 mg in 1 g)

Adapalene(1.5 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Bausch Health Companies Inc.

Labeler

Bausch Health US LLC

DUNS Number

245141858

Products1

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

Product Details

NDC Product Code

0187-0006

Application Number

NDA216632

Marketing Category

NDA (C73594)

Route of Administration

TOPICAL

Effective Date

November 7, 2023

Ingredients

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive

Code: 4Q93RCW27EClass: IACT

ClindamycinActive

Code: EH6D7113I8Class: ACTIMQuantity: 12 mg in 1 g

Benzoyl peroxideActive

Code: W9WZN9A0GMClass: ACTIBQuantity: 31 mg in 1 g

AdapaleneActive

Code: 1L4806J2QFClass: ACTIBQuantity: 1.5 mg in 1 g

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Cabtreo

FDA Approval Summary

Manufacturing Establishments1

Products1

Cabtreo

Product Details