Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021124
Company: KARO HLTHCARE
Company: KARO HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMISIL AT | TERBINAFINE HYDROCHLORIDE | 1% | SOLUTION;TOPICAL | Over-the-counter | None | Yes | Yes |
| LAMISIL AT | TERBINAFINE HYDROCHLORIDE | 1% | SPRAY;TOPICAL | Over-the-counter | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/18/2018 | SUPPL-16 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021124Orig1s016lbl.pdf | |
| 11/13/2013 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021124Orig1s013lbl.pdf | |
| 03/17/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21124lbl.pdf |