Details for New Drug Application (NDA): 212765
✉ Email this page to a colleague
NDA 212765 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.
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 212765
| Tradename: | EPLERENONE |
| Applicant: | Slate Run Pharma |
| Ingredient: | eplerenone |
| Patents: | 0 |
Pharmacology for NDA: 212765
| Mechanism of Action | Aldosterone Antagonists |
Suppliers and Packaging for NDA: 212765
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPLERENONE | eplerenone | TABLET;ORAL | 212765 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-098 | 70436-098-01 | 100 TABLET, FILM COATED in 1 BOTTLE (70436-098-01) |
| EPLERENONE | eplerenone | TABLET;ORAL | 212765 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-098 | 70436-098-04 | 30 TABLET, FILM COATED in 1 BOTTLE (70436-098-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 10, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 10, 2020 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
