Details for New Drug Application (NDA): 206922
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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 206922
Tradename: | EPLERENONE |
Applicant: | Accord Hlthcare |
Ingredient: | eplerenone |
Patents: | 0 |
Pharmacology for NDA: 206922
Mechanism of Action | Aldosterone Antagonists |
Suppliers and Packaging for NDA: 206922
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EPLERENONE | eplerenone | TABLET;ORAL | 206922 | ANDA | Accord Healthcare, Inc. | 16729-293 | 16729-293-10 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-293-10) |
EPLERENONE | eplerenone | TABLET;ORAL | 206922 | ANDA | Accord Healthcare, Inc. | 16729-293 | 16729-293-15 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-293-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 13, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 13, 2017 | TE: | AB | RLD: | No |
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