Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210740
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOFETILDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | AB | No | No |
DOFETILDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | AB | No | No |
DOFETILDE | 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 |
---|---|---|---|---|---|---|---|
01/22/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/30/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DOFETILDE
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 |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 207058 | DR REDDYS LABS SA |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 212750 | GRANULES |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 213220 | MSN |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 207746 | SIGMAPHARM LABS LLC |
DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL | Prescription | No | AB | 208519 | STRIDES PHARMA |
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 |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 207058 | DR REDDYS LABS SA |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 212750 | GRANULES |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 213220 | MSN |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 207746 | SIGMAPHARM LABS LLC |
DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL | Prescription | No | AB | 208519 | STRIDES PHARMA |
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 |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 207058 | DR REDDYS LABS SA |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 212750 | GRANULES |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 213220 | MSN |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 207746 | SIGMAPHARM LABS LLC |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 208519 | STRIDES PHARMA |
DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | No | AB | 210466 | SUN PHARM |
TIKOSYN | DOFETILIDE | 0.5MG | CAPSULE;ORAL | Prescription | Yes | AB | 020931 | PFIZER |