Drugs@FDA: FDA-Approved Drugs
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| TERBINAFINE HYDROCHLORIDE | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |