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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Johnson and Johnson
Dow
Cantor Fitzgerald
Fish and Richardson
McKesson
Novartis
QuintilesIMS
Argus Health

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090325

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NDA 090325 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Anbison Lab Co Ltd, Anchen Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharma Global, Tech Organized, Torrent Pharms Ltd, Twi Pharms Inc, Watson Labs Inc, Wockhardt Ltd, Zydus Pharms Usa Inc, Apotex Inc, Heritage Pharma, and Teva, and is included in forty-five NDAs. It is available from seventy-three suppliers. Additional details are available on the BUPROPION HYDROCHLORIDE profile page.

The generic ingredient in BUPROPION HYDROCHLORIDE is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 090325
Tradename:BUPROPION HYDROCHLORIDE
Applicant:Mylan
Ingredient:bupropion hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090325
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090325 ANDA Mylan Pharmaceuticals Inc. 0378-3411 0378-3411-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3411-05)
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090325 ANDA Mylan Pharmaceuticals Inc. 0378-3411 0378-3411-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3411-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Apr 8, 2010TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Apr 8, 2010TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Apr 8, 2010TE:AB1RLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Citi
Argus Health
Cantor Fitzgerald
US Army
Novartis
Moodys
Merck
Farmers Insurance

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