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Last Updated: May 15, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204806

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NDA 204806 describes ATAZANAVIR SULFATE, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Cipla, Mylan, Teva Pharms Usa, and Zydus Pharms, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the ATAZANAVIR SULFATE profile page.

The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.
Summary for 204806
Tradename:ATAZANAVIR SULFATE
Applicant:Aurobindo Pharma Ltd
Ingredient:atazanavir sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204806
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 204806 ANDA Major Pharmaceuticals 0904-6875 0904-6875-04 30 BLISTER PACK in 1 CARTON (0904-6875-04) > 1 CAPSULE in 1 BLISTER PACK
ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 204806 ANDA NorthStar Rx LLC 16714-860 16714-860-01 60 CAPSULE in 1 BOTTLE (16714-860-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Jun 25, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Jun 25, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Jun 25, 2018TE:ABRLD:No

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