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Fish and Richardson
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Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079094

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NDA 079094 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Prinston Inc, Teva, Impax Labs, Sandoz, Actavis Labs Fl Inc, Anchen Pharms, Tech Organized, Anbison Lab Co Ltd, Mylan, Wockhardt Ltd, Apotex Inc, Sinotherapeutics Inc, Watson Labs Inc, Invagen Pharms, Jubilant Generics, Sun Pharma Global, Zydus Pharms Usa Inc, Torrent Pharms Ltd, Sandoz Inc, Heritage Pharma, Sciegen Pharms Inc, and Lupin Ltd, and is included in forty-four 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 NDA: 079094

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: 079094

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 079094 ANDA Actavis Pharma, Inc. 0591-3543 0591-3543-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3543-60)
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 079094 ANDA Actavis Pharma, Inc. 0591-3543 0591-3543-76 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3543-76)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Mar 24, 2009TE:AB2RLD:No


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Dow
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