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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 202304

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NDA 202304 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 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, Apnar Pharma Lp, Apotex, Cadila Pharms Ltd, Heritage Pharma, Invatech, and Micro Labs, and is included in sixty-one 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-two suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 202304

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Prinston Inc
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 202304

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

Suppliers and Packaging for NDA: 202304

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202304	ANDA	Major Pharmaceuticals	0904-7099	0904-7099-61	100 BLISTER PACK in 1 CARTON (0904-7099-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202304	ANDA	Major Pharmaceuticals	0904-7465	0904-7465-61	100 BLISTER PACK in 1 CARTON (0904-7465-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	May 26, 2015	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	May 26, 2015	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	May 26, 2015	TE:	AB1	RLD:	No

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