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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
US Army
Boehringer Ingelheim
Johnson and Johnson

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040747

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NDA 040747 describes BENZPHETAMINE HYDROCHLORIDE, which is a drug marketed by Anda Repository, Emcure Pharms Ltd, Epic Pharma Llc, Impax Labs, Kvk Tech, Mallinckrodt Inc, Mikart, and Tedor Pharm, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the BENZPHETAMINE HYDROCHLORIDE profile page.

The generic ingredient in BENZPHETAMINE HYDROCHLORIDE is benzphetamine hydrochloride. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the benzphetamine hydrochloride profile page.
Summary for 040747
Applicant:Tedor Pharm
Ingredient:benzphetamine hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040747
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET;ORAL 040747 ANDA Apotheca Inc. 12634-118 12634-118-80 20 TABLET in 1 BOTTLE (12634-118-80)
BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET;ORAL 040747 ANDA Apotheca Inc. 12634-118 12634-118-78 28 TABLET in 1 BOTTLE (12634-118-78)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 30, 2007TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Nov 20, 2015TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
US Department of Justice

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