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 |
| 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 |