Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022071
Company: NOVARTIS
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-Patient Package Insert, Labeling-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 |