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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216632

CABTREO (ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE)
0.15%;3.1%;1.2%
Marketing Status: Prescription
Active Ingredient: ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Proprietary Name: CABTREO
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.15%;3.1%;1.2%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216632
Product Number: 001
Approval Date: Oct 20, 2023
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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