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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 207224

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NDA 207224 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Usa, Endo Operations, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Prinston Inc, Rising, Sandoz, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alembic, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, and Micro Labs, and is included in fifty-nine 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 207224

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Anbison Lab
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 207224

Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Suppliers and Packaging for NDA: 207224

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207224	ANDA	Epic Pharma, LLC	42806-348	42806-348-05	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-348-05)
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207224	ANDA	Epic Pharma, LLC	42806-348	42806-348-09	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-348-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Jun 30, 2017	TE:	AB3	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Jun 30, 2017	TE:	AB3	RLD:	No

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