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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 091673


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NDA 091673 describes ATAZANAVIR SULFATE, which is a drug marketed by Amneal, Aurobindo Pharma, Cipla, Hetero Labs Ltd Iii, Laurus, Mylan, Teva Pharms Usa, and Zydus Pharms, and is included in eight NDAs. It is available from eight 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. Nine suppliers are listed for this compound. Additional details are available on the atazanavir sulfate profile page.
Summary for 091673
Tradename:ATAZANAVIR SULFATE
Applicant:Teva Pharms Usa
Ingredient:atazanavir sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091673
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 091673 ANDA Teva Pharmaceuticals USA, Inc. 0093-5526 0093-5526-06 60 CAPSULE in 1 BOTTLE (0093-5526-06)
ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 091673 ANDA Teva Pharmaceuticals USA, Inc. 0093-5527 0093-5527-06 60 CAPSULE in 1 BOTTLE (0093-5527-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Apr 22, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Apr 22, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Apr 22, 2014TE:ABRLD:No

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