.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077415

« Back to Dashboard
NDA 077415 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: 077415

Tradename:
BUPROPION HYDROCHLORIDE
Applicant:
Impax Labs
Ingredient:
bupropion hydrochloride
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 0115-6811-02 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-6811-02)
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)

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


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc