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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 210497

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NDA 210497 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 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, 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-three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 210497

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Accord Hlthcare
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 210497

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

Suppliers and Packaging for NDA: 210497

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210497	ANDA	Accord Healthcare Inc.	16729-443	16729-443-10	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-10)
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210497	ANDA	Accord Healthcare Inc.	16729-443	16729-443-15	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Oct 31, 2018	TE:	AB3	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Oct 31, 2018	TE:	AB3	RLD:	No

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