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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Dow
Colorcon
Harvard Business School
Express Scripts
Fuji
Queensland Health
Fish and Richardson
QuintilesIMS

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078510

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NDA 078510 describes EPLERENONE, which is a drug marketed by Accord Hlthcare, Apotex, Mylan Pharms Inc, and Sandoz, and is included in four NDAs. It is available from seven suppliers. Additional details are available on the EPLERENONE profile page.

The generic ingredient in EPLERENONE is eplerenone. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
Summary for 078510
Tradename:EPLERENONE
Applicant:Sandoz
Ingredient:eplerenone
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078510
Mechanism of ActionAldosterone Antagonists
Suppliers and Packaging for NDA: 078510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPLERENONE eplerenone TABLET;ORAL 078510 ANDA Eon Labs, Inc. 0185-5368 N 0185-5368-09
EPLERENONE eplerenone TABLET;ORAL 078510 ANDA Eon Labs, Inc. 0185-5368 N 0185-5368-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Aug 1, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 1, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Queensland Health
Johnson and Johnson
UBS
Chubb
Dow
US Department of Justice
Citi

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