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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079246

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NDA 079246 describes ABACAVIR SULFATE AND LAMIVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Lupin Ltd, and Teva Pharms Usa, and is included in four NDAs. It is available from six suppliers. Additional details are available on the ABACAVIR SULFATE AND LAMIVUDINE profile page.

The generic ingredient in ABACAVIR SULFATE AND LAMIVUDINE is abacavir sulfate; lamivudine. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.
Summary for 079246
Applicant:Teva Pharms Usa
Ingredient:abacavir sulfate; lamivudine
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 079246
Suppliers and Packaging for NDA: 079246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246 ANDA Teva Pharmaceuticals USA, Inc. 0093-5382 N 0093-5382-56
ABACAVIR SULFATE AND LAMIVUDINE abacavir sulfate; lamivudine TABLET;ORAL 079246 ANDA AvKARE, Inc. 42291-115 N 42291-115-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 600MG BASE;300MG
Approval Date:Sep 29, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo

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