Details for New Drug Application (NDA): 076278
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NDA 076278 describes FLECAINIDE ACETATE, which is a drug marketed by Amneal Pharm, Ani Pharms, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell, Hikma, Sun Pharm Inds Ltd, and Yichang Humanwell, and is included in nine NDAs. It is available from fourteen 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.
Summary for 076278
| Tradename: | FLECAINIDE ACETATE |
| Applicant: | Hikma |
| Ingredient: | flecainide acetate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076278
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 076278 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0010 | 0054-0010-20 | 100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK |
| FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 076278 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0010 | 0054-0010-21 | 60 TABLET in 1 BOTTLE (0054-0010-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 14, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 14, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jan 14, 2003 | TE: | AB | RLD: | No | ||||
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