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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079128

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NDA 079128 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, Strides Pharma, and Teva Pharms, and is included in nine NDAs. It is available from twenty-one 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-four suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

Summary for 079128

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 079128

Suppliers and Packaging for NDA: 079128

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079128 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-411 55700-411-06 6 TABLET in 1 BOTTLE (55700-411-06)
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 079128 ANDA Strides Shasun Limited 64380-707 64380-707-03 60 TABLET in 1 BOTTLE (64380-707-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;300MG
Approval Date:May 13, 2015TE:ABRLD:No


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US Department of Justice
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