Application 213591
- Type
- NDA
- Sponsor
- NOVARTIS PHARMS CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TABRECTA | CAPMATINIB HYDROCHLORIDE | TABLET;ORAL | 150MG | Yes | No |
| 002 | TABRECTA | CAPMATINIB HYDROCHLORIDE | TABLET;ORAL | 200MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0078-0709 | TABRECTA | capmatinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0709 | TABRECTA | capmatinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0709 | TABRECTA | capmatinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0709 | TABRECTA | capmatinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0716 | TABRECTA | capmatinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0716 | TABRECTA | capmatinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0716 | TABRECTA | capmatinib | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0716 | TABRECTA | capmatinib | Novartis Pharmaceuticals Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77892 | SUPPL | 2024-03-21 |
| 77847 | SUPPL | 2024-03-15 |
| 73884 | SUPPL | 2023-03-27 |
| 73872 | SUPPL | 2023-03-27 |
| 71789 | SUPPL | 2022-08-11 |
| 71769 | SUPPL | 2022-08-11 |
| 69968 | SUPPL | 2022-01-25 |
| 69959 | SUPPL | 2022-01-25 |
| 63374 | ORIG | 2020-06-01 |
| 62845 | ORIG | 2020-05-07 |
| 62842 | ORIG | 2020-05-06 |