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Generated: October 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077455

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NDA 077455 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, Torrent Pharms Ltd, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zydus Pharms Usa Inc, Alembic Pharms Ltd, Apotex Inc, Heritage Pharma, and Teva, and is included in forty-seven NDAs. It is available from seventy-seven 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. Eighty-two suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 077455
Tradename:BUPROPION HYDROCHLORIDE
Applicant:Watson Labs Inc
Ingredient:bupropion hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077455
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077455 ANDA Liberty Pharmaceuticals, Inc. 0440-7200 0440-7200-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0440-7200-30)
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077455 ANDA Liberty Pharmaceuticals, Inc. 0440-7200 0440-7200-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0440-7200-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jul 19, 2010TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Mar 12, 2008TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Jul 19, 2010TE:AB1RLD:No

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