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Details for New Drug Application (NDA): 078510

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NDA 078510 describes EPLERENONE, which is a drug marketed by Sandoz and Apotex and is included in two NDAs. It is available from six 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. Ten suppliers are listed for this compound. Additional details are available on the eplerenone profile page.

Summary for NDA: 078510

Therapeutic Class:Cardiovascular Agents

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