Application 022545
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | TABLET;ORAL | EQ 150MG BASE;EQ 5MG BASE | No | No |
| 002 | TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | TABLET;ORAL | EQ 150MG BASE;EQ 10MG BASE | No | No |
| 003 | TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | TABLET;ORAL | EQ 300MG BASE;EQ 5MG BASE | No | No |
| 004 | TEKAMLO | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE | TABLET;ORAL | EQ 300MG BASE;EQ 10MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 45850 | SUPPL | 2016-11-08 |
| 45829 | SUPPL | 2016-11-08 |
| 17701 | SUPPL | 2015-12-28 |
| 7524 | SUPPL | 2015-12-23 |
| 38833 | SUPPL | 2015-04-02 |
| 29851 | SUPPL | 2015-04-01 |
| 17700 | SUPPL | 2014-03-19 |
| 7523 | SUPPL | 2013-11-06 |
| 17699 | SUPPL | 2013-11-04 |
| 7522 | SUPPL | 2012-10-02 |
| 7520 | SUPPL | 2012-10-02 |
| 38832 | SUPPL | 2012-10-01 |
| 17698 | SUPPL | 2012-10-01 |
| 7521 | SUPPL | 2012-04-18 |
| 17697 | SUPPL | 2012-04-16 |
| 29848 | SUPPL | 2012-02-07 |
| 38831 | SUPPL | 2012-02-06 |
| 29850 | SUPPL | 2012-02-06 |
| 38830 | SUPPL | 2012-01-31 |
| 29849 | SUPPL | 2011-11-16 |
| 17696 | SUPPL | 2011-11-14 |
| 17695 | SUPPL | 2011-10-20 |
| 29847 | SUPPL | 2011-10-14 |
| 44776 | ORIG | 2011-05-25 |
| 22052 | ORIG | 2011-05-25 |
| 38829 | SUPPL | 2011-04-01 |
| 29846 | SUPPL | 2011-04-01 |
| 7519 | ORIG | 2010-08-31 |
| 17694 | ORIG | 2010-08-27 |