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.
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
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
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: | RX | Dosage: | GEL;TOPICAL | Strength | 0.15%;3.1%;1.2% | ||||
| Approval Date: | Oct 20, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,220,049 | Patent Expiration: | Jun 3, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 10,624,918 | Patent Expiration: | Jun 3, 2029 | Product 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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