← FDA DRUG APPROVALS

FDA NDA · NDA216632

CABTREO

clindamycin phosphate/benzoyl peroxide/adapalene

Sponsor: BAUSCH

APPLICATION
NDA216632
TYPE
NDA
ORIGINAL APPROVAL
2023-10-20
LATEST ACTION
2023-10-20
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

CABTREO · ReferencePrescription
ADAPALENE 0.15%, BENZOYL PEROXIDE 3.1%, CLINDAMYCIN PHOSPHATE 1.2% · GEL · TOPICAL

Approval history

2023-10-20Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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