Last Updated: June 24, 2026

Details for New Drug Application (NDA): 078866

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NDA 078866 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Usa, Chartwell Rx, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Ipca Labs Ltd, Jubilant Generics, Lupin, Ph Health, Prinston Inc, Rising, Sandoz, Sciegen Pharms, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alembic, Apotex, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, and Senores Pharms, and is included in sixty-two NDAs. It is available from seventy-one 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-four suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 078866

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Sun Pharm
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 078866

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

Suppliers and Packaging for NDA: 078866

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078866	ANDA	Sun Pharmaceutical Industries, Inc.	47335-736	47335-736-08	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-08)
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078866	ANDA	Sun Pharmaceutical Industries, Inc.	47335-736	47335-736-13	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-736-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Apr 6, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Apr 6, 2010	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Apr 6, 2010	TE:		RLD:	No

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