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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207403

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NDA 207403 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 seventy 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 207403

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Micro Labs
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 207403

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

Suppliers and Packaging for NDA: 207403

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	207403	ANDA	Micro Labs Limited	42571-241	42571-241-01	100 TABLET, FILM COATED in 1 BOTTLE (42571-241-01)
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	207403	ANDA	Micro Labs Limited	42571-242	42571-242-01	100 TABLET, FILM COATED in 1 BOTTLE (42571-242-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Apr 17, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 17, 2020	TE:	AB	RLD:	No

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