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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019356
Company: SEBELA IRELAND LTD

Products on NDA 019356

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAFTIN	NAFTIFINE HYDROCHLORIDE	1%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019356

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/1990	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2018	SUPPL-8	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
09/26/2007	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019356s007ltr.pdf
07/01/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/30/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/24/1997	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
07/30/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019356

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf

Therapeutic Equivalents for NDA 019356

NAFTIN

GEL;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAFTIFINE HYDROCHLORIDE	NAFTIFINE HYDROCHLORIDE	1%	GEL;TOPICAL	Prescription	No	AB	206165	AMNEAL
NAFTIN	NAFTIFINE HYDROCHLORIDE	1%	GEL;TOPICAL	Prescription	Yes	AB	019356	SEBELA IRELAND LTD

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