Application 022068
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TASIGNA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | Yes | Yes |
| 002 | TASIGNA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | Yes | No |
| 003 | TASIGNA | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0526 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0526 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0526 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0526 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0526 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0526 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0526 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0592 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0592 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0592 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0592 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0592 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0592 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0592 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0951 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0951 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0951 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0951 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0951 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0951 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0951 | Tasigna | nilotinib | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79462 | SUPPL | 2024-08-22 |
| 79458 | SUPPL | 2024-08-22 |
| 77699 | SUPPL | 2024-03-04 |
| 77698 | SUPPL | 2024-03-04 |
| 77686 | SUPPL | 2024-03-01 |
| 77462 | SUPPL | 2024-02-12 |
| 77447 | SUPPL | 2024-02-09 |
| 75659 | SUPPL | 2023-10-03 |
| 75647 | SUPPL | 2023-10-03 |
| 68787 | SUPPL | 2021-09-27 |
| 68786 | SUPPL | 2021-09-27 |
| 68777 | SUPPL | 2021-09-24 |
| 68776 | SUPPL | 2021-09-24 |
| 68775 | SUPPL | 2021-09-24 |
| 65558 | SUPPL | 2020-12-10 |
| 65557 | SUPPL | 2020-12-10 |
| 65539 | SUPPL | 2020-12-09 |
| 60128 | SUPPL | 2019-09-26 |
| 60127 | SUPPL | 2019-09-26 |
| 60113 | SUPPL | 2019-09-26 |
| 55317 | SUPPL | 2018-08-24 |
| 55268 | SUPPL | 2018-08-22 |
| 53086 | SUPPL | 2018-03-22 |
| 53144 | SUPPL | 2018-03-21 |
| 50965 | SUPPL | 2017-12-29 |
| 50847 | SUPPL | 2017-12-22 |
| 47334 | SUPPL | 2017-02-27 |
| 47297 | SUPPL | 2017-02-23 |
| 45423 | SUPPL | 2016-09-30 |
| 45424 | SUPPL | 2016-09-28 |
| 38187 | SUPPL | 2015-10-22 |
| 6820 | SUPPL | 2015-10-16 |
| 38186 | SUPPL | 2015-01-30 |
| 6819 | SUPPL | 2015-01-28 |
| 38185 | SUPPL | 2014-09-30 |
| 29200 | SUPPL | 2014-09-29 |
| 29198 | SUPPL | 2014-01-23 |
| 16891 | SUPPL | 2014-01-23 |
| 38184 | SUPPL | 2013-10-01 |
| 29199 | SUPPL | 2013-10-01 |
| 38183 | SUPPL | 2013-06-18 |
| 29196 | SUPPL | 2013-06-13 |
| 29197 | SUPPL | 2013-05-28 |
| 29195 | SUPPL | 2013-05-22 |
| 6818 | SUPPL | 2012-12-26 |
| 16890 | SUPPL | 2012-12-21 |
| 29194 | SUPPL | 2012-05-03 |
| 38182 | SUPPL | 2012-05-02 |
| 38181 | SUPPL | 2011-11-25 |
| 16889 | SUPPL | 2011-11-25 |
| 29193 | SUPPL | 2011-11-22 |
| 29192 | SUPPL | 2011-11-22 |
| 29191 | SUPPL | 2011-11-01 |
| 16888 | SUPPL | 2011-11-01 |
| 29190 | SUPPL | 2011-01-20 |
| 38180 | SUPPL | 2011-01-14 |
| 29189 | SUPPL | 2010-06-22 |
| 6817 | SUPPL | 2010-06-22 |
| 38179 | SUPPL | 2010-06-17 |
| 16887 | SUPPL | 2010-06-17 |
| 6815 | SUPPL | 2010-03-18 |
| 16885 | SUPPL | 2010-03-17 |
| 6816 | SUPPL | 2010-01-21 |
| 16886 | SUPPL | 2009-09-16 |
| 44674 | ORIG | 2008-07-22 |
| 21924 | ORIG | 2008-03-14 |
| 6814 | ORIG | 2007-11-08 |
| 16884 | ORIG | 2007-10-29 |
| 64025 | ORIG | 1900-01-01 |
| 64024 | ORIG | 1900-01-01 |
| 64023 | ORIG | 1900-01-01 |
| 64022 | ORIG | 1900-01-01 |
| 63181 | SUPPL | 1900-01-01 |
| 63180 | SUPPL | 1900-01-01 |
| 63179 | SUPPL | 1900-01-01 |