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Fish and Richardson
Federal Trade Commission

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202418

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NDA 202418 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 202418
Applicant:Aurobindo Pharma Ltd
Ingredient:lamivudine; zidovudine
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 202418
Suppliers and Packaging for NDA: 202418
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 202418 ANDA Unit Dose Services 50436-0597 N 50436-0597-1
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 202418 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-096 N 55700-096-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;300MG
Approval Date:May 15, 2012TE:ABRLD:No

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