Application 022180
- Type
- NDA
- Sponsor
- AMAG PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FERAHEME | FERUMOXYTOL | SOLUTION;INTRAVENOUS | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022180-001 | FERAHEME | FERUMOXYTOL | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022180-001 | AB |
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 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2009-06-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2009-06-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2009-06-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2009-06-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2009-06-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2009-06-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022180-001 | FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | SOLUTION / INTRAVENOUS | AB | RLD, RS | 2009-06-30 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022180-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022180-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022180-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022180-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022180-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022180-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022180-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022180-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022180-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022180-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022180-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022180-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022180-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022180-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022180-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022180-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022180-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022180-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N022180-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022180-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022180-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022180-001 | AB | 1 | 5aa47cf7b7d7… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022180-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022180-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022180-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022180-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022180-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022180-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022180-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022180-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022180-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022180-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022180-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022180-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022180-001 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022180-001 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022180-001 | 7553479 | 2020-03-08 | Drug substance, Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022180-001 | 7871597 | 2020-03-08 | Drug substance, Drug product | 2011-02-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022180-001 | 8501158 | 2020-03-08 | U-1422 | 2013-08-06 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022180-001 | 8591864 | 2020-03-08 | Drug product | 2013-12-12 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022180-001 | 8926947 | 2020-03-08 | Drug substance, Drug product | 2015-01-08 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N022180-001 | 7553479 | 2020-03-08 | Drug substance, Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N022180-001 | 7871597 | 2020-03-08 | Drug substance, Drug product | 2011-02-15 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022180-001 | 8501158 | 2020-03-08 | U-1422 | 2013-08-06 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022180-001 | 8591864 | 2020-03-08 | Drug product | 2013-12-12 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022180-001 | 8926947 | 2020-03-08 | Drug substance, Drug product | 2015-01-08 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N022180-001 | 7553479 | 2020-03-08 | Drug substance, Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N022180-001 | 7871597 | 2020-03-08 | Drug substance, Drug product | 2011-02-15 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022180-001 | 8501158 | 2020-03-08 | U-1422 | 2013-08-06 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022180-001 | 8591864 | 2020-03-08 | Drug product | 2013-12-12 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022180-001 | 8926947 | 2020-03-08 | Drug substance, Drug product | 2015-01-08 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N022180-001 | 7553479 | 2020-03-08 | Drug substance, Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N022180-001 | 7871597 | 2020-03-08 | Drug substance, Drug product | 2011-02-15 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022180-001 | 8501158 | 2020-03-08 | U-1422 | 2013-08-06 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022180-001 | 8591864 | 2020-03-08 | Drug product | 2013-12-12 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022180-001 | 8926947 | 2020-03-08 | Drug substance, Drug product | 2015-01-08 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N022180-001 | 7553479 | 2020-03-08 | Drug substance, Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N022180-001 | 7871597 | 2020-03-08 | Drug substance, Drug product | 2011-02-15 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022180-001 | 8501158 | 2020-03-08 | U-1422 | 2013-08-06 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022180-001 | 8591864 | 2020-03-08 | Drug product | 2013-12-12 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022180-001 | 8926947 | 2020-03-08 | Drug substance, Drug product | 2015-01-08 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022180-001 | 6599498 | 2023-06-30 | Drug substance, Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N022180-001 | 7553479 | 2020-03-08 | Drug substance, Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N022180-001 | 7871597 | 2020-03-08 | Drug substance, Drug product | 2011-02-15 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022180-001 | 8501158 | 2020-03-08 | U-1422 | 2013-08-06 | ea99ee380514… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022180-001 | I-767 | 2021-02-02 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N022180-001 | I-767 | 2021-02-02 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022180-001 | I-767 | 2021-02-02 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022180-001 | I-767 | 2021-02-02 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022180-001 | I-767 | 2021-02-02 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022180-001 | I-767 | 2021-02-02 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022180-001 | I-767 | 2021-02-02 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022180-001 | I-767 | 2021-02-02 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022180-001 | I-767 | 2021-02-02 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Feraheme | FERUMOXYTOL | AMAG Pharmaceuticals, Inc | 32b0e320-a739-11dc-a704-0002a5d5c51b | 2026-05-31 | Boxed warning, Warnings, Adverse reactions | 022180 NDA022180 59338-775 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59338-775 | Feraheme | ferumoxytol | AMAG Pharmaceuticals, Inc. | NDA | Current |
| 59338-775 | Feraheme | ferumoxytol | AMAG Pharmaceuticals, Inc. | NDA | Current |
| 59338-775 | Feraheme | ferumoxytol | AMAG Pharmaceuticals, Inc. | NDA | Current |
| 59338-775 | Feraheme | ferumoxytol | AMAG Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71358 | SUPPL | 2022-06-21 |
| 71349 | SUPPL | 2022-06-17 |
| 64615 | SUPPL | 2020-09-21 |
| 64570 | SUPPL | 2020-09-14 |
| 60554 | SUPPL | 2019-10-15 |
| 60552 | SUPPL | 2019-10-15 |
| 52508 | SUPPL | 2018-02-08 |
| 52398 | SUPPL | 2018-02-05 |
| 50933 | SUPPL | 2017-12-27 |
| 50910 | SUPPL | 2017-12-27 |
| 38340 | SUPPL | 2015-03-19 |
| 17048 | SUPPL | 2015-03-19 |
| 29359 | SUPPL | 2015-03-17 |
| 29358 | SUPPL | 2015-03-17 |
| 17047 | SUPPL | 2013-12-24 |
| 38339 | SUPPL | 2011-06-29 |
| 29357 | SUPPL | 2011-06-28 |
| 38338 | SUPPL | 2010-12-01 |
| 38337 | SUPPL | 2010-12-01 |
| 29356 | SUPPL | 2010-11-30 |
| 7006 | SUPPL | 2010-11-30 |
| 44693 | ORIG | 2009-11-25 |
| 42438 | ORIG | 2009-11-25 |
| 29355 | ORIG | 2009-07-07 |
| 38336 | ORIG | 2009-07-02 |