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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209717

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ATAZANAVIR SULFATE (ATAZANAVIR SULFATE)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: ATAZANAVIR SULFATE
Proprietary Name: ATAZANAVIR SULFATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209717
Product Number: 002
Approval Date: Jun 1, 2020
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ATAZANAVIR SULFATE (ATAZANAVIR SULFATE)
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: ATAZANAVIR SULFATE
Proprietary Name: ATAZANAVIR SULFATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209717
Product Number: 003
Approval Date: Jun 1, 2020
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ATAZANAVIR SULFATE (ATAZANAVIR SULFATE)
EQ 300MG BASE
Marketing Status: Prescription
Active Ingredient: ATAZANAVIR SULFATE
Proprietary Name: ATAZANAVIR SULFATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209717
Product Number: 004
Approval Date: Jun 1, 2020
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ATAZANAVIR SULFATE (ATAZANAVIR SULFATE)
EQ 100MG BASE
Marketing Status: Discontinued
Active Ingredient: ATAZANAVIR SULFATE
Proprietary Name: ATAZANAVIR SULFATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209717
Product Number: 001
Approval Date: Jun 1, 2020
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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