Application 202008
- Type
- NDA
- Sponsor
- AVID RADIOPHARMS INC
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202008-001 | AMYVID | FLORBETAPIR F-18 | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | |
| N202008-002 | AMYVID | FLORBETAPIR F-18 | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | |
| N202008-003 | AMYVID | FLORBETAPIR F-18 | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | |
| N202008-004 | AMYVID | FLORBETAPIR F-18 | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202008-001 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2012-05-04 |
| N202008-001 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2013-09-06 |
| N202008-002 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | |
| N202008-002 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | |
| N202008-003 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | |
| N202008-003 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | |
| N202008-004 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 |
| N202008-004 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202008-001 | AMYVID | 10ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202008-002 | AMYVID | 10-30ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD | 2012-04-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202008-003 | AMYVID | 10-50ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2012-04-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202008-004 | AMYVID | 10-100ML (13.5-51mCi/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-10-13 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N202008-001 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2012-05-04 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202008-001 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2013-09-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202008-002 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202008-002 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202008-003 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202008-003 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202008-004 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N202008-004 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-001 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2012-05-04 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-001 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2013-09-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-002 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-002 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-003 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-003 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-004 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202008-004 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-001 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2012-05-04 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-001 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2013-09-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-002 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-002 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-003 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-003 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-004 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202008-004 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-001 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2012-05-04 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-001 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2013-09-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-002 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-002 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-003 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-003 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-004 | 7687052 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N202008-004 | 8506929 | 2027-04-30 | U-4217 | Drug substance, Drug product | 2025-07-23 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-001 | 7687052 | 2027-04-30 | Drug substance, Drug product | 2012-05-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-001 | 8506929 | 2027-04-30 | U-1423 | Drug substance, Drug product | 2013-09-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-002 | 7687052 | 2027-04-30 | Drug substance, Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-002 | 8506929 | 2027-04-30 | U-1423 | Drug substance, Drug product | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-003 | 7687052 | 2027-04-30 | Drug substance, Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202008-003 | 8506929 | 2027-04-30 | U-1423 | Drug substance, Drug product | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202008-001 | 7687052 | 2027-04-30 | Drug substance, Drug product | 2012-05-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202008-001 | 8506929 | 2027-04-30 | U-1423 | Drug substance, Drug product | 2013-09-06 | b8a1b40f171c… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Amyvid | FLORBETAPIR F 18 | Eli Lilly and Company | bb5a5043-0f51-11df-8a39-0800200c9a66 | 2025-12-11 | Warnings, Adverse reactions | 202008 NDA202008 0002-1200 |
NDC Listings For This Application#
| 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 |
|---|---|---|
| 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 |