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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211200

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NDA 211200 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-nine 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 211200

Tradename:	BUPROPION HYDROCHLORIDE
Applicant:	Zhejiang Jutai Pharm
Ingredient:	bupropion hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	Sep 5, 2019	TE:	AB3	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	150MG
Approval Date:	Apr 29, 2020	TE:	AB3	RLD:	No

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