Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022071
Company: NOVARTIS
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
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
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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