Details for New Drug Application (NDA): 216632
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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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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