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Details for New Drug Application (NDA): 076834

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NDA 076834 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Prinston Inc, Teva, Impax Labs, Sandoz, Actavis Labs Fl Inc, Anchen Pharms, Sciegen Pharms Inc, Mylan, Wockhardt Ltd, Apotex Inc, Watson Labs Inc, Invagen Pharms, Sun Pharma Global, Zydus Pharms Usa Inc, Torrent Pharms Ltd, Jubilant Generics, Sandoz Inc, and Heritage Pharma, and is included in thirty-eight 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-six drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for NDA: 076834

Tradename:
BUPROPION HYDROCHLORIDE
Applicant:
Sandoz
Ingredient:
bupropion hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Jul 14, 2005TE:RLD:No


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