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Serving leading biopharmaceutical companies globally:

Covington
US Department of Justice
Chinese Patent Office
Medtronic
Cipla
Fuji
Julphar
Dow
US Army
Colorcon

Generated: November 21, 2017

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Details for New Drug Application (NDA): 090473

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NDA 090473 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 Anda Repository, 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 090473

Tradename:
1
Applicant:
1
Ingredient:
1
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 C.O. Truxton, Inc. 0463-6050 0463-6050-01 100 TABLET in 1 BOTTLE, PLASTIC (0463-6050-01)
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride
TABLET;ORAL 090473 ANDA C.O. Truxton, Inc. 0463-6050 0463-6050-05 500 TABLET in 1 BOTTLE, PLASTIC (0463-6050-05)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Healthtrust
Merck
Express Scripts
Harvard Business School
Moodys
Johnson and Johnson
Mallinckrodt
Accenture
Federal Trade Commission
Cerilliant

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.

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