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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075584

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NDA 075584 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Anbison Lab Co Ltd, Anchen Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharma Global, Tech Organized, Torrent Pharms Ltd, Twi Pharms Inc, Watson Labs Inc, Wockhardt Ltd, Zydus Pharms Usa Inc, Apotex Inc, Heritage Pharma, and Teva, and is included in forty-five 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-seven drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 075584

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidepressants
Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

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 KAISER FOUNDATION HOSPITALS 0179-0025 0179-0025-88 600 TABLET, FILM COATED in 1 BOTTLE (0179-0025-88)
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 075584 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-5535 0615-5535-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-5535-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Feb 7, 2000TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Feb 7, 2000TE:ABRLD:No


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