Details for New Drug Application (NDA): 203896
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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 203896
Tradename: | EPLERENONE |
Applicant: | Prasco |
Ingredient: | eplerenone |
Patents: | 0 |
Pharmacology for NDA: 203896
Mechanism of Action | Aldosterone Antagonists |
Suppliers and Packaging for NDA: 203896
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPLERENONE | eplerenone | TABLET;ORAL | 203896 | ANDA | Prasco Laboratories | 66993-343 | 66993-343-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-343-30) |
EPLERENONE | eplerenone | TABLET;ORAL | 203896 | ANDA | Prasco Laboratories | 66993-343 | 66993-343-85 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-343-85) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Feb 2, 2017 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Feb 2, 2017 | TE: | RLD: | No |
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