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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Colorcon
Moodys
Daiichi Sankyo
Johnson and Johnson
Cipla
Chinese Patent Office
Fuji

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020711

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NDA 020711 describes ZYBAN, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. Additional details are available on the ZYBAN profile page.

The generic ingredient in ZYBAN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 020711
Tradename:ZYBAN
Applicant:Glaxosmithkline
Ingredient:bupropion hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020711
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711 NDA GlaxoSmithKline LLC 0173-0556 N 0173-0556-01

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:May 14, 1997TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:May 14, 1997TE:AB2RLD:Yes

Expired US Patents for NDA 020711

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Accenture
Daiichi Sankyo
US Department of Justice
Farmers Insurance
US Army
QuintilesIMS
Cantor Fitzgerald

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