Details for New Drug Application (NDA): 210740
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NDA 210740 describes DOFETILDE, which is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the DOFETILDE profile page.
The generic ingredient in DOFETILDE 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 DOFETILDE 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 210740
| Tradename: | DOFETILDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | dofetilide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210740
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOFETILDE | dofetilide | CAPSULE;ORAL | 210740 | ANDA | Aurobindo Pharma Limited | 59651-118 | 59651-118-05 | 500 CAPSULE in 1 BOTTLE (59651-118-05) |
| DOFETILDE | dofetilide | CAPSULE;ORAL | 210740 | ANDA | Aurobindo Pharma Limited | 59651-118 | 59651-118-60 | 60 CAPSULE in 1 BOTTLE (59651-118-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Jan 22, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Jan 22, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Jan 22, 2019 | TE: | AB | RLD: | No | ||||
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