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Application 214096
- Type
- NDA
- Sponsor
- EMD SERONO INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TEPMETKO | TEPOTINIB HYDROCHLORIDE | TABLET;ORAL | 225MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 44087-5000 | TEPMETKO | Tepotinib Hydrochloride | EMD Serono, Inc. | NDA | Current |
| 44087-5000 | TEPMETKO | Tepotinib Hydrochloride | EMD Serono, Inc. | NDA | Current |
| 44087-5000 | TEPMETKO | Tepotinib Hydrochloride | EMD Serono, Inc. | NDA | Current |
| 44087-5000 | TEPMETKO | Tepotinib Hydrochloride | EMD Serono, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84055 | SUPPL | 2025-11-19 |
| 77525 | SUPPL | 2024-02-16 |
| 77508 | SUPPL | 2024-02-16 |
| 73862 | SUPPL | 2023-03-24 |
| 73861 | SUPPL | 2023-03-24 |
| 73859 | SUPPL | 2023-03-24 |
| 73858 | SUPPL | 2023-03-24 |
| 66311 | ORIG | 2021-02-22 |
| 66095 | ORIG | 2021-02-05 |
| 66080 | ORIG | 2021-02-03 |