Details for New Drug Application (NDA): 078482
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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 078482
Tradename: | EPLERENONE |
Applicant: | Chartwell Rx |
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: | Jul 30, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 30, 2008 | TE: | AB | RLD: | No |
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