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Serving leading biopharmaceutical companies globally:

Covington
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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203969

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NDA 203969 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 sixty-nine 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-four suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 203969

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: 203969

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 203969 ANDA Torrent Pharmaceuticals Limited 13668-430 13668-430-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-430-01)
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 203969 ANDA Torrent Pharmaceuticals Limited 13668-430 13668-430-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-430-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Oct 31, 2014TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Oct 31, 2014TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Oct 31, 2014TE:AB1RLD:No


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Serving leading biopharmaceutical companies globally:

Teva
Daiichi Sankyo
Colorcon
Fuji
Argus Health
Chinese Patent Office
Federal Trade Commission
Deloitte
US Department of Justice
Mallinckrodt

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