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Last Updated: April 15, 2024

Details for New Drug Application (NDA): 216632


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NDA 216632 describes CABTREO, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the CABTREO profile page.

The generic ingredient in CABTREO is adapalene; benzoyl peroxide; clindamycin phosphate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the adapalene; benzoyl peroxide; clindamycin phosphate profile page.
Summary for 216632
Tradename:CABTREO
Applicant:Bausch
Ingredient:adapalene; benzoyl peroxide; clindamycin phosphate
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216632
Generic Entry Date for 216632*:
Constraining patent/regulatory exclusivity:
Dosage:
GEL;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 216632
Suppliers and Packaging for NDA: 216632
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632 NDA Bausch Health US LLC 0187-0006 0187-0006-10 1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP
CABTREO adapalene; benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 216632 NDA Bausch Health US LLC 0187-0006 0187-0006-25 1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.15%;3.1%;1.2%
Approval Date:Oct 20, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 20, 2026
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Try a TrialPatent Expiration:Jun 3, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Patent:⤷  Try a TrialPatent Expiration:Jun 3, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

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