Details for New Drug Application (NDA): 210683
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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 210683
Tradename: | FLECAINIDE ACETATE |
Applicant: | Beximco Pharms Usa |
Ingredient: | flecainide acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 210683
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 210683 | ANDA | PD-Rx Pharmaceuticals, Inc. | 72789-383 | 72789-383-01 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-383-01) |
FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 210683 | ANDA | PD-Rx Pharmaceuticals, Inc. | 72789-383 | 72789-383-60 | 60 TABLET in 1 BOTTLE, PLASTIC (72789-383-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Sep 16, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 16, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Sep 16, 2020 | TE: | AB | RLD: | No |
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