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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079081

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NDA 079081 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 079081
Tradename:LAMIVUDINE AND ZIDOVUDINE
Applicant:Teva Pharms
Ingredient:lamivudine; zidovudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 079081
Suppliers and Packaging for NDA: 079081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079081 ANDA Teva Pharmaceuticals USA, Inc. 0093-5385 N 0093-5385-06
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079081 ANDA Rebel Distributors Corp 21695-996 E 21695-996-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;300MG
Approval Date:May 25, 2011TE:ABRLD:No

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