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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 206922


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NDA 206922 describes EPLERENONE, which is a drug marketed by Accord Hlthcare, Annora Pharma, Breckenridge, Chartwell Rx, Prasco, Rising, Sandoz, Slate Run Pharma, and Westminster Pharms, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the EPLERENONE profile page.

The generic ingredient in EPLERENONE is eplerenone. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
Summary for 206922
Tradename:EPLERENONE
Applicant:Accord Hlthcare
Ingredient:eplerenone
Patents:0
Pharmacology for NDA: 206922
Mechanism of ActionAldosterone Antagonists
Suppliers and Packaging for NDA: 206922
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPLERENONE eplerenone TABLET;ORAL 206922 ANDA Accord Healthcare, Inc. 16729-293 16729-293-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-293-10)
EPLERENONE eplerenone TABLET;ORAL 206922 ANDA Accord Healthcare, Inc. 16729-293 16729-293-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-293-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 13, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 13, 2017TE:ABRLD:No

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