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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Cantor Fitzgerald
Harvard Business School
UBS
Healthtrust
Baxter
Fish and Richardson
Deloitte
Farmers Insurance

Generated: July 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090636

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NDA 090636 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 forty 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 090636
Tradename:TENOFOVIR DISOPROXIL FUMARATE
Applicant:Hetero Labs Ltd Iii
Ingredient:tenofovir disoproxil fumarate
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 090636
Suppliers and Packaging for NDA: 090636
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090636 ANDA Camber Pharmaceuticals, Inc. 31722-535 N 31722-535-01
TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090636 ANDA Camber Pharmaceuticals, Inc. 31722-535 N 31722-535-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 26, 2018TE:ABRLD:No

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