Application 214032
- Type
- NDA
- Sponsor
- TELIX PHARMACEUTICALS US INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ILLUCCIX | GOZETOTIDE;D-MANNOSE | INJECTABLE;INJECTION | 25MCG;10MCG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 74725-100 | ILLUCCIX | Kit for the preparation of gallium Ga 68 gozetotide injection | Telix Pharmaceuticals US Inc. | NDA | Current |
| 74725-100 | ILLUCCIX | Kit for the preparation of gallium Ga 68 gozetotide injection | Telix Pharmaceuticals US Inc. | NDA | Current |
| 74725-100 | ILLUCCIX | Kit for the preparation of gallium Ga 68 gozetotide injection | Telix Pharmaceuticals US Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84418 | SUPPL | 2025-12-15 |
| 84365 | SUPPL | 2025-12-09 |
| 83346 | SUPPL | 2025-09-12 |
| 83344 | SUPPL | 2025-09-12 |
| 73784 | SUPPL | 2023-03-17 |
| 73776 | SUPPL | 2023-03-16 |
| 71699 | ORIG | 2022-08-03 |
| 69722 | ORIG | 2021-12-21 |