Application 022011
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TYZEKA | TELBIVUDINE | TABLET;ORAL | 600MG | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57059 | SUPPL | 2018-12-30 |
| 57050 | SUPPL | 2018-12-28 |
| 57047 | SUPPL | 2018-12-28 |
| 53562 | SUPPL | 2018-04-01 |
| 53525 | SUPPL | 2018-03-29 |
| 29068 | SUPPL | 2013-01-30 |
| 38078 | SUPPL | 2013-01-28 |
| 38077 | SUPPL | 2013-01-28 |
| 6681 | SUPPL | 2012-01-03 |
| 16762 | SUPPL | 2011-12-23 |
| 6680 | SUPPL | 2011-05-10 |
| 38076 | SUPPL | 2011-04-01 |
| 29067 | SUPPL | 2011-04-01 |
| 16761 | SUPPL | 2010-10-04 |
| 6679 | SUPPL | 2010-09-16 |
| 16760 | SUPPL | 2010-03-09 |
| 6678 | SUPPL | 2010-03-08 |
| 16759 | SUPPL | 2009-05-13 |
| 6677 | SUPPL | 2009-05-13 |
| 16758 | SUPPL | 2009-02-04 |
| 29066 | SUPPL | 2009-01-26 |
| 21905 | ORIG | 2006-12-22 |
| 29065 | ORIG | 2006-10-27 |
| 38075 | ORIG | 2006-10-26 |