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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091612

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NDA 091612 describes TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd Iii, Laurus Labs Pvt, Macleods Pharms Ltd, Qilu Pharm Co Ltd, Strides Pharma, and Teva Pharms Usa, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are thirty-nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 091612
Tradename:TENOFOVIR DISOPROXIL FUMARATE
Applicant:Teva Pharms Usa
Ingredient:tenofovir disoproxil fumarate
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 091612
Suppliers and Packaging for NDA: 091612
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 091612 ANDA Teva Pharmaceuticals USA, Inc. 0093-7104 N 0093-7104-56
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 091612 ANDA REMEDYREPACK INC. 70518-0918 N 70518-0918-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Mar 18, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 26, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jan 26, 2018TE:ABRLD:No

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