Details for New Drug Application (NDA): 208283
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NDA 208283 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 208283
| Tradename: | EPLERENONE |
| Applicant: | Breckenridge |
| Ingredient: | eplerenone |
| Patents: | 0 |
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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