Application 203137
- Type
- NDA
- Sponsor
- GE HEALTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIZAMYL | FLUTEMETAMOL F-18 | INJECTABLE;INTRAVENOUS | 40.5mCi/10ML (4.05mCi/ML) | Yes | No |
| 002 | VIZAMYL | FLUTEMETAMOL F-18 | INJECTABLE;INTRAVENOUS | 121.5mCi/30ML (4.05mCi/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17156-067 | Vizamyl | Flutemetamol F-18 | Medi-Physics, Inc. dba GE Healthcare | NDA | Current |
| 17156-067 | Vizamyl | Flutemetamol F-18 | Medi-Physics, Inc. dba GE Healthcare | NDA | Current |
| 17156-067 | Vizamyl | Flutemetamol F-18 | Medi-Physics, Inc. dba GE Healthcare | NDA | Current |
| 17156-067 | Vizamyl | Flutemetamol F-18 | Medi-Physics, Inc. dba GE Healthcare | NDA | Current |
| 17156-067 | Vizamyl | Flutemetamol F-18 | Medi-Physics, Inc. dba GE Healthcare | NDA | Current |
| 17156-067 | Vizamyl | Flutemetamol F-18 | Medi-Physics, Inc. dba GE Healthcare | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82682 | SUPPL | 2025-06-27 |
| 82653 | SUPPL | 2025-06-24 |
| 82542 | SUPPL | 2025-06-12 |
| 82541 | SUPPL | 2025-06-11 |
| 61571 | SUPPL | 2020-01-14 |
| 61562 | SUPPL | 2020-01-14 |
| 47303 | SUPPL | 2017-02-23 |
| 47300 | SUPPL | 2017-02-23 |
| 10169 | SUPPL | 2016-04-11 |
| 19432 | SUPPL | 2016-04-08 |
| 19431 | SUPPL | 2014-12-10 |
| 10168 | SUPPL | 2014-12-05 |
| 43421 | ORIG | 2013-11-15 |
| 19430 | ORIG | 2013-10-31 |
| 32382 | ORIG | 2013-10-29 |