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Farmers Insurance
Cipla
Harvard Business School
Teva
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Chinese Patent Office
UBS
Federal Trade Commission
Fuji
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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204528

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NDA 204528 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, Strides Pharma, and Teva Pharms, and is included in twenty-three 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-two suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.
Summary for 204528
Tradename:LAMIVUDINE
Applicant:Mylan Pharms Inc
Ingredient:lamivudine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 204528
Medical Subject Heading (MeSH) Categories for 204528
Suppliers and Packaging for NDA: 204528
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAMIVUDINE lamivudine TABLET;ORAL 204528 ANDA Mylan Pharmaceuticals Inc. 0378-5169 N 0378-5169-91
LAMIVUDINE lamivudine TABLET;ORAL 204528 ANDA Mylan Pharmaceuticals Inc. 0378-5170 N 0378-5170-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Mar 4, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Mar 4, 2016TE:ABRLD:No

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