Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202008
Company: AVID RADIOPHARMS INC
Company: AVID RADIOPHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMYVID | FLORBETAPIR F-18 | 10ML (13.5-51mCi/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
| AMYVID | FLORBETAPIR F-18 | 10-30ML (13.5-51mCi/ML) | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
| AMYVID | FLORBETAPIR F-18 | 10-50ML (13.5-51mCi/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| AMYVID | FLORBETAPIR F-18 | 10-100ML (13.5-51mCi/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/06/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202008s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202008Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202008_Florbetapir_Orig1s000TOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/23/2025 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202008s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202008Orig1s046ltr.pdf | |
| 10/13/2023 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202008Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202008Orig1s044ltr.pdf | |
| 08/19/2022 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202008Orig1s041ltr.pdf |
| 12/20/2019 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202008s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202008Orig1s036ltr.pdf | |
| 06/22/2016 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2016 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/2015 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2013 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202008s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202008Orig1s020ltr.pdf | |
| 11/08/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/2013 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/23/2025 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202008s046lbl.pdf | |
| 10/13/2023 | SUPPL-44 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202008Orig1s044lbl.pdf | |
| 12/20/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202008s036lbl.pdf | |
| 12/12/2013 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202008s020lbl.pdf | |
| 04/06/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202008s000lbl.pdf |