Details for New Drug Application (NDA): 215323
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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 215323
Tradename: | DOFETILIDE |
Applicant: | Rk Pharma |
Ingredient: | dofetilide |
Patents: | 0 |
Suppliers and Packaging for NDA: 215323
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOFETILIDE | dofetilide | CAPSULE;ORAL | 215323 | ANDA | VGYAAN Pharmaceuticals LLC | 72664-229 | 72664-229-60 | 60 CAPSULE in 1 BOTTLE (72664-229-60) |
DOFETILIDE | dofetilide | CAPSULE;ORAL | 215323 | ANDA | VGYAAN Pharmaceuticals LLC | 72664-230 | 72664-230-60 | 60 CAPSULE in 1 BOTTLE (72664-230-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 0.125MG | ||||
Approval Date: | Apr 14, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 0.25MG | ||||
Approval Date: | Apr 14, 2022 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
Approval Date: | Apr 14, 2022 | TE: | RLD: | No |
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