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Generated: August 19, 2017

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 Epic Pharma Llc, Impax Labs, Tedor Pharm, Emcure Pharms Ltd, Kvk Tech, Mallinckrodt Inc, Mikart, and Twi Pharms Inc, 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 NDA: 040747

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040747

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 12634-118-00 10 TABLET in 1 BOTTLE (12634-118-00)
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride
TABLET;ORAL 040747 ANDA Apotheca Inc. 12634-118 12634-118-01 100 TABLET in 1 BOTTLE (12634-118-01)

Summary for product number 001

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

Summary for product number 002

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


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