Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213220
Company: MSN
Company: MSN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | AB | No | No |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | AB | No | No |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/29/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DOFETILIDE
CAPSULE;ORAL; 0.125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOFETILDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 210740 | AUROBINDO PHARMA LTD |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 213338 | ACCORD HLTHCARE |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 208625 | BIONPHARMA INC |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 207058 | MAYNE PHARMA INC |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 213220 | MSN |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 208519 | PAR PHARM INC |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 207746 | SIGMAPHARM LABS LLC |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 210466 | SUN PHARM |
TIKOSYN | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | Yes | AB | 020931 | PFIZER |
CAPSULE;ORAL; 0.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOFETILDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 210740 | AUROBINDO PHARMA LTD |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 213338 | ACCORD HLTHCARE |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 208625 | BIONPHARMA INC |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 207058 | MAYNE PHARMA INC |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 213220 | MSN |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 208519 | PAR PHARM INC |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 207746 | SIGMAPHARM LABS LLC |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 210466 | SUN PHARM |
TIKOSYN | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | Yes | AB | 020931 | PFIZER |
CAPSULE;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOFETILDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 210740 | AUROBINDO PHARMA LTD |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 213338 | ACCORD HLTHCARE |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 208625 | BIONPHARMA INC |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 207058 | MAYNE PHARMA INC |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 213220 | MSN |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 208519 | PAR PHARM INC |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 207746 | SIGMAPHARM LABS LLC |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 210466 | SUN PHARM |
TIKOSYN | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 020931 | PFIZER |
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