Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020931
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIKOSYN DOFETILIDE 0.125MG CAPSULE;ORAL Prescription AB Yes No
TIKOSYN DOFETILIDE 0.25MG CAPSULE;ORAL Prescription AB Yes No
TIKOSYN DOFETILIDE 0.5MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/01/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20931lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20931ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-931_Tikosyn.cfm https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/020931Orig1s013REMS.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/08/2019 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020931s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020931Orig1s017ltr.pdf
03/08/2016 SUPPL-13 REMS-Modified Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020931Orig1s012,s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020931s013.pdf
03/08/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020931Orig1s012,s013ltr.pdf
11/25/2015 SUPPL-10 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020931Orig1s010ltr.pdf
07/08/2015 SUPPL-9 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020931Orig1s009ltr.pdf
12/06/2013 SUPPL-7 Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020931s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020931Orig1s007ltr.pdf
07/11/2011 SUPPL-3 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020931s003ltr.pdf
10/18/2007 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/22/2004 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/08/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020931s017lbl.pdf
03/08/2016 SUPPL-13 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf
03/08/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020931s012s013lbl.pdf
12/06/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020931s007lbl.pdf
12/06/2013 SUPPL-7 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020931s007lbl.pdf
10/01/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20931lbl.pdf

TIKOSYN

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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