Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019599
Company: SEBELA IRELAND LTD
Company: SEBELA IRELAND LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAFTIN | NAFTIFINE HYDROCHLORIDE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |
| NAFTIN | NAFTIFINE HYDROCHLORIDE | 2% | CREAM;TOPICAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/30/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019356s008,019599s014,204286s003lbl.pdf | |
| 11/10/2016 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019599s013lbl.pdf | |
| 10/10/2014 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019599s012lbledt.pdf | |
| 01/13/2012 | SUPPL-11 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019599s011lbl.pdf |