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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019599
Company: SEBELA IRELAND LTD

Products on NDA 019599

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAFTIN	NAFTIFINE HYDROCHLORIDE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No
NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019599

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/29/1988	ORIG-1	Approval	Type 1 - New Molecular Entity	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-14	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
11/10/2016	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019599s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019599Orig1s013ltr.pdf
10/10/2014	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019599Orig1s012ltr.pdf
01/13/2012	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019599s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/019599Orig1s011.pdf
01/26/2009	SUPPL-10	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019599s010ltr.pdf
08/10/2006	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/04/2002	SUPPL-7	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019599Orig1s007.pdf
11/30/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/24/1997	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
06/15/1995	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/30/1990	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
07/05/1990	SUPPL-2	Efficacy-New Dosing Regimen		Label is not available on this site.
04/05/1989	SUPPL-1	Efficacy-New Indication		Label is not available on this site.

Labels for NDA 019599

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf
11/10/2016	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019599s013lbl.pdf
10/10/2014	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf
01/13/2012	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf

Therapeutic Equivalents for NDA 019599

NAFTIN

CREAM;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%	CREAM;TOPICAL	Prescription	No	AB	206960	AMNEAL
NAFTIFINE HYDROCHLORIDE	NAFTIFINE HYDROCHLORIDE	2%	CREAM;TOPICAL	Prescription	No	AB	206901	TARO
NAFTIFINE HYDROCHLORIDE	NAFTIFINE HYDROCHLORIDE	2%	CREAM;TOPICAL	Prescription	No	AB	210038	XIROMED
NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	CREAM;TOPICAL	Prescription	Yes	AB	019599	SEBELA IRELAND LTD

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