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Federal Trade Commission
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202032

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NDA 202032 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Lannett Co Inc, Apotex, Apotex Inc, Appco Pharma Llc, Cipla Ltd, Eci Pharms Llc, Hetero Labs Ltd V, Lupin Ltd, Mylan Pharms Inc, Strides Pharma, Hetero Labs Ltd Iii, Pharmacare, Shanghai Desano, and Teva Pharms, and is included in twenty-six NDAs. It is available from twenty suppliers. Additional details are available on the LAMIVUDINE profile page.

The generic ingredient in LAMIVUDINE 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 202032
Tradename:LAMIVUDINE
Applicant:Aurobindo Pharma Ltd
Ingredient:lamivudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 202032
Medical Subject Heading (MeSH) Categories for 202032
Suppliers and Packaging for NDA: 202032
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE lamivudine TABLET;ORAL 202032 ANDA Bryant Ranch Prepack 63629-5014 E 63629-5014-1
LAMIVUDINE lamivudine TABLET;ORAL 202032 ANDA Bryant Ranch Prepack 63629-5014 E 63629-5014-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 17, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Nov 17, 2011TE:ABRLD:No

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