Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207058
Company: MAYNE PHARMA INC
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
06/06/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207058Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207058Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/06/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207058Orig1s000lbl.pdf

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 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 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 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 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 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 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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