Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020192
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMISIL | TERBINAFINE HYDROCHLORIDE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 12/30/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/03/1998 | SUPPL-14 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020192_S014_LAMISIL_CREAM.pdf |
| 06/30/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S013_LAMISIL_CREAM.pdf |
| 04/03/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S012_LAMISIL.pdf |
| 01/21/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S011_LAMISIL.pdf |
| 10/04/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-6 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020192_S006_LAMISIL_CREAM.pdf |
| 10/17/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020192_S005_LAMISIL_CREAM.pdf |
| 04/25/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1997 | SUPPL-3 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020192_S003.pdf |
| 08/04/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |