Application 202008
- Type
- NDA
- Sponsor
- AVID RADIOPHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMYVID | FLORBETAPIR F-18 | SOLUTION;INTRAVENOUS | 10ML (13.5-51mCi/ML) | No | No |
| 002 | AMYVID | FLORBETAPIR F-18 | SOLUTION;INTRAVENOUS | 10-30ML (13.5-51mCi/ML) | Yes | Yes |
| 003 | AMYVID | FLORBETAPIR F-18 | SOLUTION;INTRAVENOUS | 10-50ML (13.5-51mCi/ML) | Yes | Yes |
| 004 | AMYVID | FLORBETAPIR F-18 | SOLUTION;INTRAVENOUS | 10-100ML (13.5-51mCi/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0002-1200 | Amyvid | Florbetapir F 18 | Eli Lilly and Company | NDA | Current |
| 0002-1200 | Amyvid | Florbetapir F 18 | Eli Lilly and Company | NDA | Current |
| 0002-1200 | Amyvid | Florbetapir F 18 | Eli Lilly and Company | NDA | Current |
| 0002-1200 | Amyvid | Florbetapir F 18 | Eli Lilly and Company | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83047 | SUPPL | 2025-08-05 |
| 83046 | SUPPL | 2025-08-05 |
| 83045 | SUPPL | 2025-08-05 |
| 82652 | SUPPL | 2025-06-24 |
| 82649 | SUPPL | 2025-06-24 |
| 61442 | SUPPL | 2019-12-26 |
| 61388 | SUPPL | 2019-12-23 |
| 19044 | SUPPL | 2013-12-17 |
| 9941 | SUPPL | 2013-12-16 |
| 43377 | ORIG | 2012-05-03 |
| 19043 | ORIG | 2012-04-09 |
| 32150 | ORIG | 2012-04-06 |