Details for New Drug Application (NDA): 213338
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NDA 213338 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 213338
| Tradename: | DOFETILIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | dofetilide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213338
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOFETILIDE | dofetilide | CAPSULE;ORAL | 213338 | ANDA | Accord Healthcare, Inc. | 16729-490 | 16729-490-12 | 60 CAPSULE in 1 BOTTLE (16729-490-12) |
| DOFETILIDE | dofetilide | CAPSULE;ORAL | 213338 | ANDA | Accord Healthcare, Inc. | 16729-491 | 16729-491-12 | 60 CAPSULE in 1 BOTTLE (16729-491-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Jun 19, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Jun 19, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Jun 19, 2020 | TE: | AB | RLD: | No | ||||
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