Application 022527
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GILENYA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | Yes | Yes |
| 002 | GILENYA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.25MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0607 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0607 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0607 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0607 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0607 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0607 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0607 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0607 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0965 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0965 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0965 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0965 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0965 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0965 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0965 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0965 | Gilenya | Fingolimod hcl | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83195 | SUPPL | 2025-08-26 |
| 83186 | SUPPL | 2025-08-25 |
| 83185 | SUPPL | 2025-08-25 |
| 78721 | SUPPL | 2024-06-07 |
| 78687 | SUPPL | 2024-06-06 |
| 76869 | SUPPL | 2023-12-15 |
| 75049 | SUPPL | 2023-12-05 |
| 75043 | SUPPL | 2023-08-11 |
| 61501 | SUPPL | 2020-01-02 |
| 61462 | SUPPL | 2019-12-27 |
| 59747 | SUPPL | 2019-09-20 |
| 59746 | SUPPL | 2019-09-20 |
| 59794 | SUPPL | 2019-08-21 |
| 59793 | SUPPL | 2019-08-21 |
| 59792 | SUPPL | 2019-08-21 |
| 59791 | SUPPL | 2019-08-21 |
| 57261 | SUPPL | 2019-01-18 |
| 57194 | SUPPL | 2019-01-14 |
| 56166 | SUPPL | 2018-10-30 |
| 54197 | SUPPL | 2018-05-15 |
| 54171 | SUPPL | 2018-05-11 |
| 50834 | SUPPL | 2017-12-22 |
| 50783 | SUPPL | 2017-12-20 |
| 45973 | SUPPL | 2016-12-01 |
| 17684 | SUPPL | 2016-02-23 |
| 7508 | SUPPL | 2016-02-23 |
| 29835 | SUPPL | 2015-08-06 |
| 17685 | SUPPL | 2015-08-06 |
| 7507 | SUPPL | 2015-07-10 |
| 17683 | SUPPL | 2015-07-06 |
| 7506 | SUPPL | 2015-05-19 |
| 38818 | SUPPL | 2015-05-04 |
| 7505 | SUPPL | 2015-05-04 |
| 17682 | SUPPL | 2014-05-02 |
| 29833 | SUPPL | 2014-05-01 |
| 29834 | SUPPL | 2013-05-29 |
| 7504 | SUPPL | 2012-05-11 |
| 38817 | SUPPL | 2012-05-10 |
| 38816 | SUPPL | 2012-03-20 |
| 29832 | SUPPL | 2012-03-20 |
| 7503 | SUPPL | 2012-03-05 |
| 44188 | ORIG | 2011-12-21 |
| 38814 | SUPPL | 2011-07-25 |
| 7502 | SUPPL | 2011-07-25 |
| 38815 | SUPPL | 2011-07-06 |
| 44771 | ORIG | 2011-02-17 |
| 22046 | ORIG | 2010-11-12 |
| 7501 | ORIG | 2010-09-27 |
| 17681 | ORIG | 2010-09-23 |
| 66911 | ORIG | 1900-01-01 |
| 63006 | SUPPL | 1900-01-01 |
| 63005 | SUPPL | 1900-01-01 |
| 63004 | SUPPL | 1900-01-01 |
| 63003 | SUPPL | 1900-01-01 |