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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health
Federal Trade Commission

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203259

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NDA 203259 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 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 203259
Applicant:Hetero Labs Ltd V
Ingredient:lamivudine; zidovudine
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 203259
Suppliers and Packaging for NDA: 203259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 203259 ANDA Camber Pharmaceuticals, Inc. 31722-739 N 31722-739-05
LAMIVUDINE AND ZIDOVUDINE lamivudine; zidovudine TABLET;ORAL 203259 ANDA Camber Pharmaceuticals, Inc. 31722-739 N 31722-739-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;300MG
Approval Date:Feb 3, 2014TE:ABRLD:No

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