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Details for New Drug Application (NDA): 091673

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NDA 091673 describes ATAZANAVIR SULFATE, which is a drug marketed by Teva Pharms Usa and is included in one NDA. Additional details are available on the ATAZANAVIR SULFATE profile page.

The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. There are twelve tentative approvals for this compound. Additional details are available on the atazanavir sulfate profile page.

Summary for NDA: 091673

Tradename:
ATAZANAVIR SULFATE
Applicant:
Teva Pharms Usa
Ingredient:
atazanavir sulfate
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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