Application 212123
- Type
- NDA
- Sponsor
- AVID RADIOPHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TAUVID | FLORTAUCIPIR F18 | INJECTABLE;INJECTION | 370MBQ(10MCI) | Yes | No |
| 002 | TAUVID | FLORTAUCIPIR F-18 | SOLUTION;INTRAVENOUS | 50ML (8.1-51mCi/ML) | Yes | Yes |
| 003 | TAUVID | FLORTAUCIPIR F-18 | SOLUTION;INTRAVENOUS | 50ML (8.1-100mCi/ML) | Yes | No |
| 004 | TAUVID | FLORTAUCIPIR F-18 | SOLUTION;INTRAVENOUS | 100ML (8.1-100mCi/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0002-1210 | TAUVID | Flortaucipir F-18 | Eli Lilly and Company | NDA | Current |
| 0002-1210 | TAUVID | Flortaucipir F-18 | Eli Lilly and Company | NDA | Current |
| 0002-1210 | TAUVID | Flortaucipir F-18 | Eli Lilly and Company | NDA | Current |
| 0002-1220 | TAUVID | Flortaucipir F-18 | Eli Lilly and Company | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77408 | SUPPL | 2024-02-07 |
| 77402 | SUPPL | 2024-02-06 |
| 74962 | SUPPL | 2023-07-31 |
| 63943 | ORIG | 2020-07-16 |
| 63363 | ORIG | 2020-06-01 |
| 63334 | ORIG | 2020-05-29 |