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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204286
Company: SEBELA IRELAND LTD

Summary Review

Products on NDA 204286

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204286

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204286s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204286Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204286_naftin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204286Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204286s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204286Orig1s004ltr.pdf
04/30/2018	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019356Orig1s008,019599Orig1s014,204286Orig1s003ltr.pdf
09/24/2014	SUPPL-2	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204286Orig1s002ltr.pdf
10/10/2014	SUPPL-1	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204286s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204286Orig1s001ltr.pdf

Labels for NDA 204286

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204286s004lbl.pdf
04/30/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf
10/10/2014	SUPPL-1	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204286s001lbl.pdf
06/27/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204286s000lbl.pdf

Therapeutic Equivalents for NDA 204286

NAFTIN

GEL;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAFTIFINE HYDROCHLORIDE	NAFTIFINE HYDROCHLORIDE	2%	GEL;TOPICAL	Prescription	No	AB	208201	TARO
NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	GEL;TOPICAL	Prescription	Yes	AB	204286	SEBELA IRELAND LTD

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