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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020539
Company: NOVARTIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMISIL TERBINAFINE HYDROCHLORIDE EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/10/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2019 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020539Orig1s033ltr.pdf
01/19/2017 SUPPL-29 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
11/15/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.
11/03/2016 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
08/23/2016 SUPPL-26 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020539Orig1s026ltr.pdf
02/12/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
10/23/2013 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s024ltr.pdf
06/17/2013 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020539Orig1s023ltr.pdf
04/23/2012 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020539s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020539s021ltr.pdf
11/04/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s020ltr.pdf
03/30/2011 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020539s018ltr.pdf
12/02/2010 SUPPL-17 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020539s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020539s017ltr.pdf
11/10/2005 SUPPL-13 Labeling

Label is not available on this site.
01/21/2004 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539slr012_lamisil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20539slr012ltr.pdf
12/27/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
04/13/2001 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20539S10ltr.pdf
04/30/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
02/01/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
04/21/1999 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/05/1999 SUPPL-3 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.
10/04/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
12/06/1996 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/29/2019 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf
01/19/2017 SUPPL-29 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf
08/23/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf
08/23/2016 SUPPL-26 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020539s026lbl.pdf
10/23/2013 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s024lbl.pdf
06/17/2013 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020539s023lbl.pdf
04/23/2012 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020539s021lbl.pdf
11/04/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s020lbl.pdf
03/30/2011 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020539s018lbl.pdf
12/02/2010 SUPPL-17 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020539s017lbl.pdf
01/21/2004 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20539slr012_lamisil_lbl.pdf
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