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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 075932

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NDA 075932 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Annora Pharma, Aurobindo Pharma Usa, Endo Operations, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, 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 Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, and Micro Labs, and is included in fifty-eight NDAs. It is available from seventy-two 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-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 075932

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	bupropion hydrochloride
Patents:	0

Pharmacology for NDA: 075932

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

Suppliers and Packaging for NDA: 075932

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	075932	ANDA	Eon Labs, Inc.	0185-0410	0185-0410-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0410-01)
BUPROPION HYDROCHLORIDE	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	075932	ANDA	Eon Labs, Inc.	0185-0410	0185-0410-60	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0410-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Nov 25, 2003	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Mar 22, 2004	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	Jun 22, 2005	TE:	AB1	RLD:	No

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