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Last Updated: May 15, 2021

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Details for New Drug Application (NDA): 200626

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NDA 200626 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 200626
Tradename:ATAZANAVIR SULFATE
Applicant:Cipla
Ingredient:atazanavir sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200626
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 200626 ANDA Cipla USA Inc. 69097-443 69097-443-02 30 CAPSULE, GELATIN COATED in 1 BOTTLE (69097-443-02)
ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 200626 ANDA Cipla USA Inc. 69097-443 69097-443-03 60 CAPSULE, GELATIN COATED in 1 BOTTLE (69097-443-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Aug 9, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 9, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Aug 9, 2018TE:ABRLD:No

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