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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022071
Company: NOVARTIS

Medication Guide

Products on NDA 022071

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMISIL	TERBINAFINE HYDROCHLORIDE	EQ 125MG BASE/PACKET	GRANULE;ORAL	Discontinued	None	Yes	No
LAMISIL	TERBINAFINE HYDROCHLORIDE	EQ 187.5MG BASE/PACKET	GRANULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022071

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022071s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022071_lamisil_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022071s015lbl.pdf
01/19/2017	SUPPL-13	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020539Orig1s029,022071Orig1s013ltr.pdf
08/23/2016	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022071Orig1s011ltr.pdf
10/23/2013	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022071s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022071Orig1s010ltr.pdf
06/17/2013	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022071s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022071Orig1s009ltr.pdf
04/23/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022071s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022071s007ltr.pdf
11/04/2011	SUPPL-6	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022071s006ltr.pdf
03/30/2011	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022071s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022071s004ltr.pdf
12/02/2010	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022071s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022071s003ltr.pdf

Labels for NDA 022071

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022071s015lbl.pdf
01/19/2017	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf
10/23/2013	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022071s010lbl.pdf
06/17/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022071s009lbl.pdf
04/23/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022071s007lbl.pdf
03/30/2011	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022071s004lbl.pdf
12/02/2010	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022071s003lbl.pdf
09/28/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022071lbl.pdf

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