Details for New Drug Application (NDA): 207746
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NDA 207746 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 sixteen 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. Eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 207746
| Tradename: | DOFETILIDE |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | dofetilide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207746
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOFETILIDE | dofetilide | CAPSULE;ORAL | 207746 | ANDA | AvKARE | 42291-411 | 42291-411-60 | 60 CAPSULE in 1 BOTTLE, PLASTIC (42291-411-60) |
| DOFETILIDE | dofetilide | CAPSULE;ORAL | 207746 | ANDA | AvKARE | 42291-412 | 42291-412-60 | 60 CAPSULE in 1 BOTTLE, PLASTIC (42291-412-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Mar 26, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Mar 26, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Mar 26, 2018 | TE: | AB | RLD: | No | ||||
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