Details for New Drug Application (NDA): 078510
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The generic ingredient in EPLERENONE is eplerenone. There are five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
Summary for 078510
Tradename: | EPLERENONE |
Applicant: | Sandoz |
Ingredient: | eplerenone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078510
Mechanism of Action | Aldosterone Antagonists |
Suppliers and Packaging for NDA: 078510
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPLERENONE | eplerenone | TABLET;ORAL | 078510 | ANDA | Eon Labs, Inc. | 0185-5368 | 0185-5368-09 | 90 TABLET in 1 BOTTLE (0185-5368-09) |
EPLERENONE | eplerenone | TABLET;ORAL | 078510 | ANDA | Eon Labs, Inc. | 0185-5368 | 0185-5368-30 | 30 TABLET in 1 BOTTLE (0185-5368-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Aug 1, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Aug 1, 2008 | TE: | AB | RLD: | No |
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