Application 207997
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYDAPT | MIDOSTAURIN | CAPSULE;ORAL | 25MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0078-0698 | RYDAPT | RYDAPT | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0698 | RYDAPT | RYDAPT | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0698 | RYDAPT | RYDAPT | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0698 | RYDAPT | RYDAPT | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0698 | RYDAPT | RYDAPT | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0698 | RYDAPT | RYDAPT | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0698 | RYDAPT | RYDAPT | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0698 | RYDAPT | RYDAPT | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74351 | SUPPL | 2023-05-23 |
| 74349 | SUPPL | 2023-05-23 |
| 69344 | SUPPL | 2021-11-18 |
| 69322 | SUPPL | 2021-11-16 |
| 67151 | SUPPL | 2021-04-22 |
| 67137 | SUPPL | 2021-04-22 |
| 65356 | SUPPL | 2020-11-27 |
| 65334 | SUPPL | 2020-11-25 |
| 62051 | SUPPL | 2020-03-05 |
| 62043 | SUPPL | 2020-03-05 |
| 54703 | SUPPL | 2018-06-27 |
| 54693 | SUPPL | 2018-06-27 |
| 48162 | ORIG | 2017-06-28 |
| 48161 | ORIG | 2017-06-28 |
| 48639 | ORIG | 2017-06-05 |
| 48163 | ORIG | 2017-04-28 |
| 48160 | ORIG | 2017-04-28 |