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Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Harvard Business School
Boehringer Ingelheim

Generated: December 17, 2017

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

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 0185-5368-09 90 TABLET in 1 BOTTLE (0185-5368-09)
EPLERENONE eplerenone TABLET;ORAL 078510 ANDA Eon Labs, Inc. 0185-5368 0185-5368-30 30 TABLET in 1 BOTTLE (0185-5368-30)

Summary for product number 001

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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Argus Health
Express Scripts
US Department of Justice
Johnson and Johnson
Daiichi Sankyo

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