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Serving leading biopharmaceutical companies globally:

Julphar
Fuji
Accenture
Express Scripts
Cantor Fitzgerald
Queensland Health
Covington
McKinsey
QuintilesIMS
Fish and Richardson

Generated: October 18, 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 Sandoz, Accord Hlthcare, Apotex, and Mylan Pharms Inc, 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 NDA: 078510

Tradename:
1
Applicant:
1
Ingredient:
1
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 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:

Chubb
Accenture
Farmers Insurance
Cipla
QuintilesIMS
Cerilliant
Julphar
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Cantor Fitzgerald
Baxter

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