Application 022071
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GRANULE;ORAL | EQ 125MG BASE/PACKET | Yes | No |
| 002 | LAMISIL | TERBINAFINE HYDROCHLORIDE | GRANULE;ORAL | EQ 187.5MG BASE/PACKET | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58167 | SUPPL | 2019-04-01 |
| 56373 | SUPPL | 2018-11-08 |
| 46957 | SUPPL | 2017-01-24 |
| 46947 | SUPPL | 2017-01-24 |
| 45230 | SUPPL | 2016-08-23 |
| 38192 | SUPPL | 2013-10-25 |
| 6827 | SUPPL | 2013-10-25 |
| 29202 | SUPPL | 2013-06-18 |
| 38191 | SUPPL | 2013-06-17 |
| 6826 | SUPPL | 2012-04-25 |
| 16894 | SUPPL | 2012-04-23 |
| 6825 | SUPPL | 2011-11-08 |
| 16893 | SUPPL | 2011-04-01 |
| 6824 | SUPPL | 2011-03-31 |
| 6823 | SUPPL | 2010-12-07 |
| 38190 | SUPPL | 2010-12-04 |
| 21926 | ORIG | 2009-03-12 |
| 38189 | ORIG | 2007-10-04 |
| 6822 | ORIG | 2007-10-04 |
| 53414 | ORIG | 1900-01-01 |
| 53413 | ORIG | 1900-01-01 |
| 53412 | ORIG | 1900-01-01 |