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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077415

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NDA 077415 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 077415

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: 077415

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077415 ANDA Impax Generics 0115-6811 0115-6811-08 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-6811-08)
BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077415 ANDA Impax Generics 0115-6811 0115-6811-02 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-6811-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Nov 26, 2008TE:AB3RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Dec 15, 2006TE:RLD:No


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