Details for New Drug Application (NDA): 022128

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NDA 022128 describes SELZENTRY, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the SELZENTRY profile page.

The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the maraviroc profile page.

Summary for 022128

Tradename:	SELZENTRY
Applicant:	Viiv Hlthcare
Ingredient:	maraviroc
Patents:	0

Pharmacology for NDA: 022128

Mechanism of Action	Chemokine Co-receptor 5 Antagonists

Suppliers and Packaging for NDA: 022128

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SELZENTRY	maraviroc	TABLET;ORAL	022128	NDA	ViiV Healthcare Company	49702-223	49702-223-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-223-18)
SELZENTRY	maraviroc	TABLET;ORAL	022128	NDA	ViiV Healthcare Company	49702-224	49702-224-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Aug 6, 2007	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Aug 6, 2007	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Nov 4, 2016	TE:		RLD:	Yes

Expired US Patents for NDA 022128

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-003	Nov 4, 2016	6,586,430	⤷ Subscribe
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-002	Aug 6, 2007	6,586,430	⤷ Subscribe
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-004	Nov 4, 2016	6,586,430	⤷ Subscribe
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128-001	Aug 6, 2007	6,586,430	⤷ Subscribe
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