Details for New Drug Application (NDA): 214663
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The generic ingredient in EPLERENONE is eplerenone. There are five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
Summary for 214663
Tradename: | EPLERENONE |
Applicant: | Rising |
Ingredient: | eplerenone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Mar 23, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 23, 2022 | TE: | AB | RLD: | No |
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