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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 075584

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NDA 075584 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 075584

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Apnar Pharma Lp
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 075584

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

Suppliers and Packaging for NDA: 075584

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	075584	ANDA	Apnar Pharma LP	24689-119	24689-119-01	100 TABLET, FILM COATED in 1 BOTTLE (24689-119-01)
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET;ORAL	075584	ANDA	Apnar Pharma LP	24689-120	24689-120-01	100 TABLET, FILM COATED in 1 BOTTLE (24689-120-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Feb 7, 2000	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Feb 7, 2000	TE:	AB	RLD:	No

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