Details for New Drug Application (NDA): 208625
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NDA 208625 describes DOFETILIDE, which is a drug marketed by Accord Hlthcare, Bionpharma, Dr Reddys Labs Sa, Granules, MSN, Novast Labs, Prinston Inc, Rk Pharma, Sigmapharm Labs Llc, Strides Pharma, Sun Pharm, and Teva Pharms Usa, and is included in twelve NDAs. It is available from fourteen suppliers. Additional details are available on the DOFETILIDE profile page.
The generic ingredient in DOFETILIDE is dofetilide. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
The generic ingredient in DOFETILIDE is dofetilide. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 208625
| Tradename: | DOFETILIDE |
| Applicant: | Bionpharma |
| Ingredient: | dofetilide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208625
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOFETILIDE | dofetilide | CAPSULE;ORAL | 208625 | ANDA | Bionpharma Inc. | 69452-131 | 69452-131-17 | 60 CAPSULE in 1 BOTTLE (69452-131-17) |
| DOFETILIDE | dofetilide | CAPSULE;ORAL | 208625 | ANDA | Bionpharma Inc. | 69452-132 | 69452-132-17 | 60 CAPSULE in 1 BOTTLE (69452-132-17) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Apr 10, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Apr 10, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Apr 10, 2018 | TE: | AB | RLD: | No | ||||
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