Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212278

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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: A212278
Product Number: 001
Approval Date: Feb 2, 2022
Applicant Holder Full Name: HETERO LABS LTD UNIT III
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: A212278
Product Number: 002
Approval Date: Feb 2, 2022
Applicant Holder Full Name: HETERO LABS LTD UNIT III
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: A212278
Product Number: 003
Approval Date: Feb 2, 2022
Applicant Holder Full Name: HETERO LABS LTD UNIT III
Marketing Status:  Prescription
Patent and Exclusivity Information