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Fish and Richardson
Argus Health

Generated: January 23, 2019

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Details for New Drug Application (NDA): 206352

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NDA 206352 describes REYATAZ, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from six suppliers. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the REYATAZ profile page.

The generic ingredient in REYATAZ is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.
Summary for 206352
Applicant:Bristol Myers Squibb
Ingredient:atazanavir sulfate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206352
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REYATAZ atazanavir sulfate POWDER;ORAL 206352 NDA E.R. Squibb & Sons, L.L.C. 0003-3638 0003-3638-10 30 PACKET in 1 CARTON (0003-3638-10) > 1 POWDER in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 50MG BASE/PACKET
Approval Date:Jun 2, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 24, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Mar 24, 2019
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Try a Free TrialPatent Expiration:Jun 21, 2019Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Fish and Richardson
Daiichi Sankyo

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