Details for New Drug Application (NDA): 202821
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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 202821
Tradename: | FLECAINIDE ACETATE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | flecainide acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 202821
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 202821 | ANDA | A-S Medication Solutions | 50090-5267 | 50090-5267-0 | 60 TABLET in 1 BOTTLE (50090-5267-0) |
FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 202821 | ANDA | A-S Medication Solutions | 50090-5306 | 50090-5306-0 | 60 TABLET in 1 BOTTLE (50090-5306-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 3, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Nov 3, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Nov 3, 2017 | TE: | AB | RLD: | No |
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