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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091612

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TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)
150MG
Marketing Status: Prescription
Active Ingredient: TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091612
Product Number: 002
Approval Date: Jan 26, 2018
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)
200MG
Marketing Status: Prescription
Active Ingredient: TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091612
Product Number: 003
Approval Date: Jan 26, 2018
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)
250MG
Marketing Status: Prescription
Active Ingredient: TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091612
Product Number: 004
Approval Date: Jan 26, 2018
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE)
300MG
Marketing Status: Prescription
Active Ingredient: TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091612
Product Number: 001
Approval Date: Mar 18, 2015
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information
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