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Last Updated: April 26, 2024

Details for New Drug Application (NDA): 050819

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NDA 050819 describes ONEXTON, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ONEXTON profile page.

The generic ingredient in ONEXTON is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

Summary for 050819

Tradename:	ONEXTON
Applicant:	Bausch
Ingredient:	benzoyl peroxide; clindamycin phosphate
Patents:	9

Pharmacology for NDA: 050819

Physiological Effect	Decreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 050819

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819	NDA	Bausch Health US, LLC	0187-3050	0187-3050-35	3.5 g in 1 TUBE (0187-3050-35)
ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819	NDA	Bausch Health US, LLC	0187-3050	0187-3050-35	3.5 g in 1 TUBE (0187-3050-35)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	2.5%;EQ 1.2% BASE
Approval Date:	Oct 23, 2008	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 3, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 3, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
Patent:	⤷ Try a Trial	Patent Expiration:	Aug 5, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACNE

Expired US Patents for NDA 050819

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	⤷ Try a Trial	⤷ Try a Trial
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	⤷ Try a Trial	⤷ Try a Trial
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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