Last Updated: August 8, 2026

Details for New Drug Application (NDA): 206122

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NDA 206122 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, Macleods Pharms Ltd, 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-three NDAs. It is available from sixty-nine 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-three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 206122

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Sciegen Pharms
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 206122

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

Suppliers and Packaging for NDA: 206122

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206122	ANDA	Dr. Reddy's Laboratories Inc	43598-863	43598-863-10	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-10)
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206122	ANDA	Dr. Reddy's Laboratories Inc	43598-863	43598-863-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Aug 17, 2016	TE:	AB2	RLD:	No

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