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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Chubb
Daiichi Sankyo
Federal Trade Commission
Mallinckrodt
Citi
Johnson and Johnson
Colorcon
McKinsey

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079124

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NDA 079124 describes LAMIVUDINE AND ZIDOVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Mylan Pharms Inc, Pharmacare, Shanghai Desano, Strides Pharma, and Teva Pharms, and is included in ten NDAs. It is available from twenty suppliers. Additional details are available on the LAMIVUDINE AND ZIDOVUDINE profile page.

The generic ingredient in LAMIVUDINE AND ZIDOVUDINE is lamivudine; zidovudine. There are twenty-eight drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.
Summary for 079124
Tradename:LAMIVUDINE AND ZIDOVUDINE
Applicant:Hetero Labs Ltd Iii
Ingredient:lamivudine; zidovudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 079124
Suppliers and Packaging for NDA: 079124
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079124 ANDA Camber Pharmaceuticals, Inc. 31722-506 N 31722-506-60
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079124 ANDA Camber Pharmaceuticals, Inc. 31722-506 N 31722-506-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;300MG
Approval Date:Sep 17, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Accenture
Fuji
Chinese Patent Office
Teva
Medtronic
Harvard Business School
Daiichi Sankyo
Healthtrust

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