Details for New Drug Application (NDA): 213220
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The generic ingredient in DOFETILIDE is dofetilide. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dofetilide profile page.
Summary for 213220
Tradename: | DOFETILIDE |
Applicant: | Msn |
Ingredient: | dofetilide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213220
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOFETILIDE | dofetilide | CAPSULE;ORAL | 213220 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-130 | 69539-130-38 | 4 BLISTER PACK in 1 CARTON (69539-130-38) / 10 CAPSULE in 1 BLISTER PACK (69539-130-11) |
DOFETILIDE | dofetilide | CAPSULE;ORAL | 213220 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-130 | 69539-130-60 | 60 CAPSULE in 1 BOTTLE (69539-130-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.125MG | ||||
Approval Date: | Jan 29, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MG | ||||
Approval Date: | Jan 29, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MG | ||||
Approval Date: | Jan 29, 2020 | TE: | AB | RLD: | No |
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