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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203277

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NDA 203277 describes LAMIVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Silarx Pharms Inc, Apotex, Apotex Inc, Appco Pharma Llc, Cipla Ltd, Eci Pharms Llc, Hetero Labs Ltd V, Lupin Ltd, Mylan Pharms Inc, Hetero Labs Ltd Iii, Pharmacare, Shanghai Desano, Strides Pharma, and Teva Pharms, and is included in twenty-four NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.
Summary for 203277
Tradename:LAMIVUDINE
Applicant:Hetero Labs Ltd V
Ingredient:lamivudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 203277
Medical Subject Heading (MeSH) Categories for 203277
Suppliers and Packaging for NDA: 203277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE lamivudine TABLET;ORAL 203277 ANDA Camber Pharmaceuticals, Inc. 31722-753 N 31722-753-60
LAMIVUDINE lamivudine TABLET;ORAL 203277 ANDA Camber Pharmaceuticals, Inc. 31722-753 N 31722-753-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 6, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 6, 2014TE:ABRLD:No

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