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Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077284

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NDA 077284 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, 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-two 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: 077284

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: 077284

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 077284 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7560 0615-7560-39 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-7560-39)
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL 077284 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7915 0615-7915-39 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-7915-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:Dec 14, 2006TE:AB3RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Dec 14, 2006TE:AB3RLD:No


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