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Drugs@FDA: FDA-Approved Drugs

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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	REMS-Modified, Labeling-Package Insert	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	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020931s007lbl.pdf
12/06/2013	SUPPL-7	Labeling-Package Insert	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

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