Application 200045
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 150MG BASE;EQ 5MG BASE;12.5MG | No | No |
| 002 | AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;EQ 5MG BASE;12.5MG | No | No |
| 003 | AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;EQ 5MG BASE;25MG | No | No |
| 004 | AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;EQ 10MG BASE;12.5MG | No | No |
| 005 | AMTURNIDE | ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | EQ 300MG BASE;EQ 10MG BASE;25MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 45852 | SUPPL | 2016-11-08 |
| 45827 | SUPPL | 2016-11-08 |
| 18945 | SUPPL | 2015-12-28 |
| 9795 | SUPPL | 2015-12-23 |
| 18944 | SUPPL | 2015-04-02 |
| 32004 | SUPPL | 2015-04-01 |
| 40002 | SUPPL | 2014-03-19 |
| 32003 | SUPPL | 2013-11-06 |
| 18943 | SUPPL | 2013-11-04 |
| 9794 | SUPPL | 2012-10-02 |
| 9793 | SUPPL | 2012-10-02 |
| 40001 | SUPPL | 2012-10-01 |
| 39999 | SUPPL | 2012-10-01 |
| 32002 | SUPPL | 2012-04-18 |
| 40000 | SUPPL | 2012-04-16 |
| 39997 | SUPPL | 2012-02-17 |
| 32000 | SUPPL | 2012-02-17 |
| 18942 | SUPPL | 2012-02-06 |
| 9792 | SUPPL | 2012-02-06 |
| 39998 | SUPPL | 2012-01-31 |
| 32001 | SUPPL | 2012-01-30 |
| 9791 | SUPPL | 2011-11-07 |
| 18941 | SUPPL | 2011-11-04 |
| 39996 | SUPPL | 2011-10-20 |
| 18940 | SUPPL | 2011-10-20 |
| 31999 | SUPPL | 2011-10-14 |
| 9790 | SUPPL | 2011-10-14 |
| 24381 | ORIG | 2011-08-15 |
| 22826 | ORIG | 2011-08-15 |
| 9789 | ORIG | 2010-12-28 |
| 18939 | ORIG | 2010-12-26 |