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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090473

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NDA 090473 describes BENZPHETAMINE HYDROCHLORIDE, which is a drug marketed by Anda Repository, Emcure Pharms Ltd, Epic Pharma Llc, Impax Labs, Kvk Tech, Mikart, Specgx Llc, and Tedor Pharm, and is included in nine NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the benzphetamine hydrochloride profile page.
Summary for 090473
Tradename:BENZPHETAMINE HYDROCHLORIDE
Applicant:Mikart
Ingredient:benzphetamine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 090473
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET;ORAL 090473 ANDA Mikart, Inc. 46672-844 N 46672-844-50
BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET;ORAL 090473 ANDA Mikart, Inc. 46672-844 N 46672-844-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 15, 2010TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 15, 2010TE:AARLD:No

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