Application 022154
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TYZEKA | TELBIVUDINE | SOLUTION;ORAL | 100MG/5ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57060 | SUPPL | 2018-12-30 |
| 57049 | SUPPL | 2018-12-28 |
| 57048 | SUPPL | 2018-12-28 |
| 53564 | SUPPL | 2018-04-01 |
| 53524 | SUPPL | 2018-03-29 |
| 17026 | SUPPL | 2013-02-12 |
| 29331 | SUPPL | 2013-01-30 |
| 29330 | SUPPL | 2012-01-03 |
| 38314 | SUPPL | 2011-12-23 |
| 29329 | SUPPL | 2011-05-10 |
| 29328 | SUPPL | 2011-04-01 |
| 17025 | SUPPL | 2011-04-01 |
| 17024 | SUPPL | 2010-10-04 |
| 29327 | SUPPL | 2010-09-16 |
| 17023 | SUPPL | 2010-03-09 |
| 6973 | SUPPL | 2010-03-08 |
| 44685 | ORIG | 2009-11-10 |
| 21947 | ORIG | 2009-11-10 |
| 38313 | ORIG | 2009-05-11 |
| 6972 | ORIG | 2009-05-06 |