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Serving leading biopharmaceutical companies globally:

Cerilliant
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Novartis
Daiichi Sankyo
Teva
Baxter
Accenture
Healthtrust
Moodys
Boehringer Ingelheim

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202912

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NDA 202912 describes ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE profile page.

The generic ingredient in ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE is abacavir sulfate; lamivudine; zidovudine. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine; zidovudine profile page.
Summary for 202912
Tradename:ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
Applicant:Lupin Ltd
Ingredient:abacavir sulfate; lamivudine; zidovudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 202912
Suppliers and Packaging for NDA: 202912
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912 ANDA LUPIN LIMITED 57297-286 57297-286-01 1 BOTTLE in 1 CARTON (57297-286-01) > 100 TABLET in 1 BOTTLE
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate; lamivudine; zidovudine TABLET;ORAL 202912 ANDA LUPIN LIMITED 57297-286 57297-286-02 1 BOTTLE in 1 CARTON (57297-286-02) > 500 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE;150MG;300MG
Approval Date:Dec 5, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Julphar
Mallinckrodt
US Department of Justice
McKinsey
Chubb
Merck
Fuji
Chinese Patent Office

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