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Application 761091
- Type
- BLA
- Sponsor
- CELLTRION INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HERZUMA | TRASTUZUMAB-PKRB | INJECTABLE;INJECTION | 420MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63459-303 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-303 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-303 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-303 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | trastuzumab | Cephalon, Inc. | BLA | Current |
| 63459-305 | HERZUMA | TRASTUZUMAB | Cephalon, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82412 | SUPPL | 2025-06-02 |
| 82333 | SUPPL | 2025-05-27 |
| 80218 | SUPPL | 2024-11-14 |
| 80211 | SUPPL | 2024-11-14 |
| 58780 | SUPPL | 2019-05-17 |
| 58779 | SUPPL | 2019-05-17 |
| 58777 | SUPPL | 2019-05-17 |
| 58776 | SUPPL | 2019-05-17 |
| 58058 | ORIG | 2019-03-21 |
| 56911 | ORIG | 2018-12-21 |
| 56747 | ORIG | 2018-12-14 |