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Last Updated: December 5, 2019

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Details for New Drug Application (NDA): 208652

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NDA 208652 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Anchen Pharms, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alembic Pharms Ltd, Apnar Pharma Lp, Apotex Inc, and Heritage Pharma, and is included in fifty-one NDAs. It is available from seventy-two 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-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 208652
Applicant:Sinotherapeutics Inc
Ingredient:bupropion hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 208652 ANDA Sandoz Inc. 0781-5528 0781-5528-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5528-10)
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 208652 ANDA Sandoz Inc. 0781-5528 0781-5528-31 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5528-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Aug 21, 2017TE:AB3RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Aug 21, 2017TE:AB3RLD:No

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