Application 021588
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLEEVEC | IMATINIB MESYLATE | TABLET;ORAL | EQ 100MG BASE | Yes | No |
| 002 | GLEEVEC | IMATINIB MESYLATE | TABLET;ORAL | EQ 400MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0401 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0649 | Gleevec | imatinib mesylate | Novartis Pharmaceuticals Corporation | NDA | Current |
| 66828-0030 | Gleevec | imatinib mesylate | Novartis Pharma Produktions GmbH | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84783 | SUPPL | 2026-01-20 |
| 84758 | SUPPL | 2026-01-15 |
| 77776 | SUPPL | 2024-03-11 |
| 77773 | SUPPL | 2024-03-11 |
| 71855 | SUPPL | 2022-08-22 |
| 71854 | SUPPL | 2022-08-22 |
| 70610 | SUPPL | 2022-03-25 |
| 64261 | SUPPL | 2020-08-11 |
| 64260 | SUPPL | 2020-08-11 |
| 64255 | SUPPL | 2020-08-11 |
| 64254 | SUPPL | 2020-08-11 |
| 55319 | SUPPL | 2018-08-24 |
| 55270 | SUPPL | 2018-08-22 |
| 49930 | SUPPL | 2017-10-03 |
| 49920 | SUPPL | 2017-10-03 |
| 49698 | SUPPL | 2017-09-08 |
| 49680 | SUPPL | 2017-09-07 |
| 48142 | SUPPL | 2017-04-27 |
| 48097 | SUPPL | 2017-04-25 |
| 45472 | SUPPL | 2016-10-04 |
| 45425 | SUPPL | 2016-09-29 |
| 45170 | SUPPL | 2016-08-25 |
| 45169 | SUPPL | 2016-08-25 |
| 45064 | SUPPL | 2016-08-25 |
| 45063 | SUPPL | 2016-08-25 |
| 21747 | SUPPL | 2015-05-26 |
| 15838 | SUPPL | 2015-02-03 |
| 28198 | SUPPL | 2015-02-02 |
| 37293 | SUPPL | 2014-05-28 |
| 5804 | SUPPL | 2014-05-22 |
| 37292 | SUPPL | 2013-10-31 |
| 5803 | SUPPL | 2013-10-31 |
| 37291 | SUPPL | 2013-02-26 |
| 5802 | SUPPL | 2013-02-25 |
| 37290 | SUPPL | 2013-01-30 |
| 5801 | SUPPL | 2013-01-30 |
| 5800 | SUPPL | 2012-02-03 |
| 15837 | SUPPL | 2012-01-31 |
| 28197 | SUPPL | 2011-04-06 |
| 5799 | SUPPL | 2011-04-06 |
| 37289 | SUPPL | 2011-04-01 |
| 37288 | SUPPL | 2011-04-01 |
| 15836 | SUPPL | 2009-06-05 |
| 28195 | SUPPL | 2009-06-02 |
| 5798 | SUPPL | 2009-06-02 |
| 28196 | SUPPL | 2009-02-13 |
| 37287 | SUPPL | 2009-02-12 |
| 5797 | SUPPL | 2008-12-29 |
| 28194 | SUPPL | 2008-10-01 |
| 28193 | SUPPL | 2008-10-01 |
| 5795 | SUPPL | 2008-10-01 |
| 37286 | SUPPL | 2008-09-26 |
| 37285 | SUPPL | 2008-09-26 |
| 37284 | SUPPL | 2008-09-26 |
| 5796 | SUPPL | 2008-05-05 |
| 28192 | SUPPL | 2007-09-25 |
| 37283 | SUPPL | 2007-09-19 |
| 37279 | SUPPL | 2006-11-06 |
| 5790 | SUPPL | 2006-11-06 |
| 37282 | SUPPL | 2006-10-23 |
| 37281 | SUPPL | 2006-10-23 |
| 28191 | SUPPL | 2006-10-23 |
| 28189 | SUPPL | 2006-10-23 |
| 15834 | SUPPL | 2006-10-23 |
| 15833 | SUPPL | 2006-10-23 |
| 15832 | SUPPL | 2006-10-23 |
| 5794 | SUPPL | 2006-10-23 |
| 5793 | SUPPL | 2006-10-23 |
| 5792 | SUPPL | 2006-10-23 |
| 42224 | SUPPL | 2006-10-19 |
| 42223 | SUPPL | 2006-10-19 |
| 42222 | SUPPL | 2006-10-19 |
| 21749 | SUPPL | 2006-10-19 |
| 21748 | SUPPL | 2006-10-19 |
| 28190 | SUPPL | 2006-10-02 |
| 15835 | SUPPL | 2006-09-28 |
| 42219 | ORIG | 2006-06-07 |
| 5791 | SUPPL | 2006-06-02 |
| 37280 | SUPPL | 2006-06-01 |
| 15831 | SUPPL | 2005-10-25 |
| 5789 | SUPPL | 2005-10-25 |
| 28188 | SUPPL | 2005-05-20 |
| 5788 | SUPPL | 2005-05-20 |
| 42221 | SUPPL | 2005-04-08 |
| 28187 | SUPPL | 2005-03-18 |
| 15830 | SUPPL | 2005-03-18 |
| 42220 | SUPPL | 2004-08-09 |
| 37278 | SUPPL | 2004-06-25 |
| 28186 | SUPPL | 2004-06-25 |
| 5787 | SUPPL | 2003-12-22 |
| 44136 | ORIG | 2003-12-09 |
| 15829 | SUPPL | 2003-12-08 |
| 5786 | SUPPL | 2003-06-08 |
| 28185 | ORIG | 2003-05-29 |
| 15828 | SUPPL | 2003-05-20 |
| 15827 | ORIG | 2003-04-28 |
| 51978 | SUPPL | 1900-01-01 |
| 51977 | SUPPL | 1900-01-01 |
| 51976 | SUPPL | 1900-01-01 |
| 51975 | SUPPL | 1900-01-01 |