Details for New Drug Application (NDA): 215599
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The generic ingredient in FLECAINIDE ACETATE is flecainide acetate. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.
Summary for 215599
Tradename: | FLECAINIDE ACETATE |
Applicant: | Yichang Humanwell |
Ingredient: | flecainide acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 215599
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 215599 | ANDA | Epic Pharma, LLC | 42806-817 | 42806-817-01 | 100 TABLET in 1 BOTTLE (42806-817-01) |
FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 215599 | ANDA | Epic Pharma, LLC | 42806-818 | 42806-818-01 | 100 TABLET in 1 BOTTLE (42806-818-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 8, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 8, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Sep 8, 2022 | TE: | AB | RLD: | No |
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