Application 215841
- Type
- NDA
- Sponsor
- ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOCAMETZ KIT | GALLIUM GA 68 GOZETOTIDE | POWDER;INTRAVENOUS | 37MCI/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69488-017 | LOCAMETZ | kit for the preparation of gallium Ga 68 gozetotide | Advanced Accelerator Applications USA, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81898 | SUPPL | 2025-04-09 |
| 81779 | SUPPL | 2025-03-31 |
| 71293 | ORIG | 2022-06-14 |
| 71200 | ORIG | 2022-06-02 |
| 70597 | ORIG | 2022-03-24 |