Details for New Drug Application (NDA): 209661

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NDA 209661 describes BONJESTA, which is a drug marketed by Duchesnay and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BONJESTA profile page.

The generic ingredient in BONJESTA is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.

Summary for 209661

Tradename:	BONJESTA
Applicant:	Duchesnay
Ingredient:	doxylamine succinate; pyridoxine hydrochloride
Patents:	4

Pharmacology for NDA: 209661

Ingredient-type	Analogs/Derivatives Vitamin B 6
Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 209661

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120	55494-120-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)
BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661	NDA	Duchesnay USA, Inc.	55494-120	55494-120-60	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MG;20MG
Approval Date:	Nov 7, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 18, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
Patent:	⤷ Sign Up	Patent Expiration:	Feb 18, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
Patent:	⤷ Sign Up	Patent Expiration:	Feb 18, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

Expired US Patents for NDA 209661

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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