Details for New Drug Application (NDA): 208283
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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 208283
Tradename: | EPLERENONE |
Applicant: | Breckenridge |
Ingredient: | eplerenone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208283
Mechanism of Action | Aldosterone Antagonists |
Suppliers and Packaging for NDA: 208283
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPLERENONE | eplerenone | TABLET;ORAL | 208283 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-877 | 51991-877-11 | 10 BLISTER PACK in 1 CARTON (51991-877-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-877-99) |
EPLERENONE | eplerenone | TABLET;ORAL | 208283 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-877 | 51991-877-33 | 30 TABLET, FILM COATED in 1 BOTTLE (51991-877-33) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Sep 14, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 14, 2018 | TE: | AB | RLD: | No |
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