Deeper Knowledge, Faster

  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

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

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
US Department of Justice

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090346

« Back to Dashboard

NDA 090346 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 090346
Applicant:Epic Pharma Llc
Ingredient:benzphetamine hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090346
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET;ORAL 090346 ANDA Epic Pharma, LLC 42806-081 42806-081-30 30 TABLET, FILM COATED in 1 BOTTLE (42806-081-30)
BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET;ORAL 090346 ANDA Epic Pharma, LLC 42806-081 42806-081-05 500 TABLET, FILM COATED in 1 BOTTLE (42806-081-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Dec 15, 2015TE:AARLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Johnson and Johnson
Express Scripts

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.