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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075913

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NDA 075913 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 075913
Tradename:BUPROPION HYDROCHLORIDE
Applicant:Impax Labs
Ingredient:bupropion hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075913
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 075913 ANDA Cardinal Health 55154-8250 55154-8250-4 100 POUCH in 1 CARTON (55154-8250-4) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (55154-8250-6)
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 075913 ANDA Cardinal Health 55154-8255 55154-8255-4 100 POUCH in 1 CARTON (55154-8255-4) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (55154-8255-6)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jan 28, 2004TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Mar 22, 2004TE:AB1RLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Julphar
Novartis
UBS
Cantor Fitzgerald
AstraZeneca
QuintilesIMS
Fuji
US Army

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