An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020931
Company: PFIZER

Medication Guide

Products on NDA 020931

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020931

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	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/020931Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/020931Orig1s001.pdf

Labels for NDA 020931

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

Therapeutic Equivalents for NDA 020931

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	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

Top