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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 079074

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LOPINAVIR AND RITONAVIR (LOPINAVIR; RITONAVIR)
100MG;25MG
Marketing Status: Prescription
Active Ingredient: LOPINAVIR; RITONAVIR
Proprietary Name: LOPINAVIR AND RITONAVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079074
Product Number: 001
Approval Date: Feb 7, 2024
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
LOPINAVIR AND RITONAVIR (LOPINAVIR; RITONAVIR)
200MG;50MG
Marketing Status: Prescription
Active Ingredient: LOPINAVIR; RITONAVIR
Proprietary Name: LOPINAVIR AND RITONAVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A079074
Product Number: 002
Approval Date: Feb 7, 2024
Applicant Holder Full Name: MYLAN LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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