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Serving leading biopharmaceutical companies globally:

Express Scripts

Last Updated: November 30, 2023

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. There is one patent protecting this drug and one Paragraph IV challenge. 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
Applicant:Viiv Hlthcare
Formulation / Manufacturing:see details
Pharmacology for NDA: 208984
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:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Nov 4, 2016TE: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
Patent:⤷  Try a TrialPatent Expiration:May 25, 2023Product Flag?Substance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson

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