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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091215

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: A091215
Product Number: 001
Approval Date: Nov 9, 2018
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
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