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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204287

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE)
600MG;200MG;300MG
Marketing Status: Prescription
Active Ingredient: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG;200MG;300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204287
Product Number: 001
Approval Date: Sep 13, 2021
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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