Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020846
Company: KARO HLTHCARE
Company: KARO HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMISIL | TERBINAFINE | 1% | GEL;TOPICAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
04/29/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20846lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20846ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020846.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/26/1999 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20846s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20846s1ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/26/1999 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20846s001lbl.pdf | |
04/29/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20846lbl.pdf |