Application 208547
- Type
- NDA
- Sponsor
- AAA USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NETSPOT | GALLIUM DOTATATE GA-68 | POWDER;INTRAVENOUS | 2.1-5.5mCi/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69488-001 | NETSPOT | 68Ga-DOTATATE | Advanced Accelerator Applications USA, Inc | NDA | Current |
| 69488-001 | NETSPOT | 68Ga-DOTATATE | Advanced Accelerator Applications USA, Inc | NDA | Current |
| 69488-001 | NETSPOT | 68Ga-DOTATATE | Advanced Accelerator Applications USA, Inc | NDA | Current |
| 69488-001 | NETSPOT | 68Ga-DOTATATE | Advanced Accelerator Applications USA, Inc | NDA | Current |
| 69488-001 | NETSPOT | 68Ga-DOTATATE | Advanced Accelerator Applications USA, Inc | NDA | Current |
| 69488-001 | NETSPOT | 68Ga-DOTATATE | Advanced Accelerator Applications USA, Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75975 | SUPPL | 2023-10-27 |
| 75967 | SUPPL | 2023-10-27 |
| 69781 | SUPPL | 2021-12-27 |
| 69765 | SUPPL | 2021-12-27 |
| 67910 | SUPPL | 2021-06-28 |
| 67909 | SUPPL | 2021-06-28 |
| 67891 | SUPPL | 2021-06-24 |
| 67890 | SUPPL | 2021-06-24 |
| 53690 | SUPPL | 2018-04-16 |
| 53666 | SUPPL | 2018-04-13 |
| 46958 | SUPPL | 2017-01-24 |
| 46951 | SUPPL | 2017-01-24 |
| 45225 | SUPPL | 2016-09-02 |
| 45202 | SUPPL | 2016-09-02 |
| 44977 | ORIG | 2016-06-21 |
| 43549 | ORIG | 2016-06-21 |
| 10657 | ORIG | 2016-06-06 |
| 19996 | ORIG | 2016-06-02 |