Details for New Drug Application (NDA): 075442
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NDA 075442 describes FLECAINIDE ACETATE, which is a drug marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Chartwell, Hikma, Regcon Holdings, Sun Pharm Inds Ltd, and Yichang Humanwell, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the FLECAINIDE ACETATE profile page.
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.
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 075442
| Tradename: | FLECAINIDE ACETATE |
| Applicant: | Amneal Pharm |
| Ingredient: | flecainide acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075442
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 075442 | ANDA | A-S Medication Solutions | 50090-6810 | 50090-6810-0 | 60 TABLET in 1 BOTTLE (50090-6810-0) |
| FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 075442 | ANDA | AvPAK | 50268-320 | 50268-320-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-320-15) / 1 TABLET in 1 BLISTER PACK (50268-320-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 31, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 31, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jul 31, 2001 | TE: | AB | RLD: | No | ||||
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