Application 020539
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMISIL | TERBINAFINE HYDROCHLORIDE | TABLET;ORAL | EQ 250MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0179 | Lamisil | terbinafine hydrochloride | Novartis Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58212 | SUPPL | 2019-04-04 |
| 58174 | SUPPL | 2019-04-02 |
| 58168 | SUPPL | 2019-04-01 |
| 46956 | SUPPL | 2017-01-24 |
| 46949 | SUPPL | 2017-01-24 |
| 45402 | SUPPL | 2016-09-28 |
| 45232 | SUPPL | 2016-08-23 |
| 25138 | SUPPL | 2013-10-25 |
| 12697 | SUPPL | 2013-10-25 |
| 2692 | SUPPL | 2013-06-18 |
| 34801 | SUPPL | 2013-06-17 |
| 34800 | SUPPL | 2012-05-02 |
| 2691 | SUPPL | 2012-04-27 |
| 34799 | SUPPL | 2012-03-22 |
| 25137 | SUPPL | 2011-11-08 |
| 34798 | SUPPL | 2011-04-01 |
| 2690 | SUPPL | 2011-03-31 |
| 2689 | SUPPL | 2010-12-06 |
| 34797 | SUPPL | 2010-12-04 |
| 34796 | SUPPL | 2004-02-03 |
| 2688 | SUPPL | 2004-02-02 |
| 25135 | ORIG | 2001-05-03 |
| 25136 | SUPPL | 2001-04-13 |