Last Updated: May 30, 2026

Details for New Drug Application (NDA): 217898

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NDA 217898 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, Apotex, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, and Senores Pharms, and is included in sixty-one 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 217898

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Annora Pharma
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 217898

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

Suppliers and Packaging for NDA: 217898

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	217898	ANDA	Camber Pharmaceuticals, Inc.	31722-487	31722-487-05	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-487-05)
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	217898	ANDA	Camber Pharmaceuticals, Inc.	31722-487	31722-487-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-487-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Oct 1, 2025	TE:	AB3	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Oct 1, 2025	TE:	AB3	RLD:	No

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