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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.