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Details for New Drug Application (NDA): 206353

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NDA 206353 describes EVOTAZ, which is a drug marketed by Bristol-myers Squibb and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the EVOTAZ profile page.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the atazanavir sulfate; cobicistat profile page.

Suppliers and Packaging for NDA: 206353

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
atazanavir sulfate; cobicistat
TABLET;ORAL 206353 NDA E.R. Squibb & Sons, L.L.C. 0003-3641 0003-3641-11 30 TABLET in 1 BOTTLE (0003-3641-11)
atazanavir sulfate; cobicistat
TABLET;ORAL 206353 NDA A-S Medication Solutions 50090-1724 50090-1724-0 30 TABLET in 1 BOTTLE (50090-1724-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE;150MG
Approval Date:Jan 29, 2015TE:RLD:Yes
Patent:5,849,911*PEDPatent Expiration:Dec 20, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,087,383*PEDPatent Expiration:Jun 21, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:8,148,374Patent Expiration:Sep 3, 2029Product Flag?YSubstance Flag?YDelist Request?

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