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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 208984

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NDA 208984 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. Five suppliers are listed for this compound. Additional details are available on the maraviroc profile page.

Summary for 208984

Tradename:	SELZENTRY
Applicant:	Viiv Hlthcare
Ingredient:	maraviroc
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 208984

Mechanism of Action	Chemokine Co-receptor 5 Antagonists

Suppliers and Packaging for NDA: 208984

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SELZENTRY	maraviroc	SOLUTION;ORAL	208984	NDA	ViiV Healthcare Company	49702-237	49702-237-55	1 BOTTLE in 1 CARTON (49702-237-55) / 230 mL in 1 BOTTLE
SELZENTRY	maraviroc	SOLUTION;ORAL	208984	NDA	ViiV Healthcare Company	49702-260	49702-260-55	1 KIT in 1 CARTON (49702-260-55) * 230 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	20MG/ML
Approval Date:	Nov 4, 2016	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 30, 2023
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Apr 30, 2024
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 208984

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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