Application 022217
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALTURNA | ALISKIREN HEMIFUMARATE; VALSARTAN | TABLET;ORAL | EQ 150MG BASE;160MG | No | No |
| 002 | VALTURNA | ALISKIREN HEMIFUMARATE; VALSARTAN | TABLET;ORAL | EQ 300MG BASE;320MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 29419 | SUPPL | 2012-04-27 |
| 38398 | SUPPL | 2012-04-26 |
| 38396 | SUPPL | 2012-02-07 |
| 38397 | SUPPL | 2012-02-06 |
| 29418 | SUPPL | 2012-02-06 |
| 29417 | SUPPL | 2012-01-30 |
| 38395 | SUPPL | 2011-10-20 |
| 29416 | SUPPL | 2011-10-17 |
| 38394 | SUPPL | 2011-05-05 |
| 7064 | SUPPL | 2011-05-05 |
| 7063 | SUPPL | 2011-02-14 |
| 17097 | SUPPL | 2011-02-11 |
| 38393 | SUPPL | 2010-08-10 |
| 7062 | SUPPL | 2010-08-09 |
| 44705 | ORIG | 2010-05-06 |
| 42453 | ORIG | 2010-05-06 |
| 7061 | ORIG | 2009-10-26 |
| 38392 | ORIG | 2009-09-21 |