Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090513

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE)
200MG;300MG
Marketing Status: Prescription
Active Ingredient: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090513
Product Number: 001
Approval Date: Jan 26, 2018
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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