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Generated: September 21, 2017

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Details for New Drug Application (NDA): 076711

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NDA 076711 describes BUPROPION HYDROCHLORIDE, which is a drug marketed by Prinston Inc, Teva, Impax Labs, Sandoz, Actavis Labs Fl Inc, Anchen Pharms, Sciegen Pharms Inc, 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, and Lupin Ltd, and is included in forty-three NDAs. It is available from sixty-eight 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-three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for NDA: 076711

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: 076711

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 076711 ANDA Impax Generics 0115-5445 0115-5445-13 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13)
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 076711 ANDA Bryant Ranch Prepack 63629-3332 63629-3332-1 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-3332-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Dec 3, 2004TE:AB1RLD:No


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Moodys
Cipla
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Healthtrust
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Cerilliant

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.

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