Application 022352
- Type
- NDA
- Sponsor
- TAKEDA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COLCRYS | COLCHICINE | TABLET;ORAL | 0.6MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022352-001 | COLCRYS | COLCHICINE | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2009-07-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022352-001 | 7964647 | 2028-10-06 | U-1007 | 2011-06-24 | |
| N022352-001 | 7964648 | 2028-10-06 | U-1161 | 2011-06-24 | |
| N022352-001 | 7981938 | 2028-10-06 | U-1166 | 2011-07-22 | |
| N022352-001 | 8093296 | 2028-10-06 | U-1007 | 2012-01-13 | |
| N022352-001 | 8093297 | 2028-10-06 | U-1161 | 2012-01-13 | |
| N022352-001 | 8093298 | 2028-10-06 | U-1116 | 2012-01-13 | |
| N022352-001 | 8097655 | 2028-10-06 | U-1020 | 2012-01-27 | |
| N022352-001 | 8415395 | 2028-10-06 | U-1007 | 2013-05-08 | |
| N022352-001 | 8415396 | 2028-10-06 | U-1007 | 2013-05-08 | |
| N022352-001 | 7619004 | 2028-12-03 | U-1020 | ||
| N022352-001 | 7935731 | 2028-12-03 | U-1116 | 2011-06-24 | |
| N022352-001 | 7601758 | 2029-02-10 | U-1007 | ||
| N022352-001 | 7820681 | 2029-02-17 | U-1020 | ||
| N022352-001 | 7906519 | 2029-02-17 | U-1116 | ||
| N022352-001 | 7915269 | 2029-02-17 | U-1007 | ||
| N022352-001 | 8440721 | 2029-02-17 | U-1007 | 2013-06-10 | |
| N022352-001 | 8440722 | 2029-02-17 | U-1020 | 2013-06-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | COLCRYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2009-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | N022352-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022352-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022352-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022352-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022352-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022352-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022352-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022352-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022352-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022352-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022352-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022352-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022352-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022352-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022352-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022352-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022352-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022352-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022352-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022352-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022352-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022352-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022352-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022352-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022352-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022352-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022352-001 | AB | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7964647 | 2028-10-06 | U-1007 | 2011-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7964648 | 2028-10-06 | U-1161 | 2011-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7981938 | 2028-10-06 | U-1166 | 2011-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8093296 | 2028-10-06 | U-1007 | 2012-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8093297 | 2028-10-06 | U-1161 | 2012-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8093298 | 2028-10-06 | U-1116 | 2012-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8097655 | 2028-10-06 | U-1020 | 2012-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8415395 | 2028-10-06 | U-1007 | 2013-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8415396 | 2028-10-06 | U-1007 | 2013-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7619004 | 2028-12-03 | U-1020 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7935731 | 2028-12-03 | U-1116 | 2011-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7601758 | 2029-02-10 | U-1007 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7820681 | 2029-02-17 | U-1020 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7906519 | 2029-02-17 | U-1116 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7915269 | 2029-02-17 | U-1007 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8440721 | 2029-02-17 | U-1007 | 2013-06-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8440722 | 2029-02-17 | U-1020 | 2013-06-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7964647 | 2028-10-06 | U-1007 | 2011-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7964648 | 2028-10-06 | U-1161 | 2011-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7981938 | 2028-10-06 | U-1166 | 2011-07-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8093296 | 2028-10-06 | U-1007 | 2012-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8093297 | 2028-10-06 | U-1161 | 2012-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8093298 | 2028-10-06 | U-1116 | 2012-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8097655 | 2028-10-06 | U-1020 | 2012-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8415395 | 2028-10-06 | U-1007 | 2013-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8415396 | 2028-10-06 | U-1007 | 2013-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7619004 | 2028-12-03 | U-1020 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7935731 | 2028-12-03 | U-1116 | 2011-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7601758 | 2029-02-10 | U-1007 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7820681 | 2029-02-17 | U-1020 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7906519 | 2029-02-17 | U-1116 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7915269 | 2029-02-17 | U-1007 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8440721 | 2029-02-17 | U-1007 | 2013-06-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8440722 | 2029-02-17 | U-1020 | 2013-06-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 7964647 | 2028-10-06 | U-1007 | 2011-06-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 7964648 | 2028-10-06 | U-1161 | 2011-06-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 7981938 | 2028-10-06 | U-1166 | 2011-07-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 8093296 | 2028-10-06 | U-1007 | 2012-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 8093297 | 2028-10-06 | U-1161 | 2012-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 8093298 | 2028-10-06 | U-1116 | 2012-01-13 | 6a471c1ec25d… |
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 |
|---|---|---|---|---|---|---|
| COLCHICINE | COLCHICINE | direct rx | c7d013b7-0a67-0953-e053-2a95a90ac47c | 2025-01-20 | Warnings, Adverse reactions | 022352 NDA022352 72189-249 |
| Colchicine | COLCHICINE | Bryant Ranch Prepack | a15538ee-d1eb-4118-97c3-53748cea012a | 2024-05-22 | Warnings, Adverse reactions | 022352 NDA022352 71335-1802 |
| Colchicine | COLCHICINE | Bryant Ranch Prepack | df1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96 | 2024-01-10 | Warnings, Adverse reactions | 022352 NDA022352 63629-2167 |
| Colchicine | COLCHICINE | Bryant Ranch Prepack | 5e5d9488-d9d0-4b37-b535-941d66c3430d | 2024-01-10 | Warnings, Adverse reactions | 022352 NDA022352 63629-2166 |
| Colcrys | COLCHICINE | Proficient Rx LP | d6adc880-5499-4691-93f3-27c87902d5fc | 2022-10-01 | Warnings, Adverse reactions | 022352 NDA022352 63187-292 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0254-2008 | Colchicine | Colchicine | Par Pharmaceutical, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0254-2008 | Colchicine | Colchicine | Par Pharmaceutical, Inc. | NDA AUTHORIZED GENERIC | Current |
| 0254-2008 | Colchicine | Colchicine | Par Pharmaceutical, Inc. | NDA AUTHORIZED GENERIC | Current |
| 13310-119 | Colcrys | Colchicine | AR Scientific Inc. | NDA | Current |
| 43353-854 | Colcrys | Colchicine | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 43353-854 | Colcrys | Colchicine | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 60687-389 | Colchicine | Colchicine | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-389 | Colchicine | Colchicine | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 60687-389 | Colchicine | Colchicine | American Health Packaging | NDA AUTHORIZED GENERIC | Current |
| 63187-292 | Colcrys | Colchicine | Proficient Rx LP | NDA | Current |
| 63187-292 | Colcrys | Colchicine | Proficient Rx LP | NDA | Current |
| 63187-292 | Colcrys | Colchicine | Proficient Rx LP | NDA | Current |
| 63629-2166 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2166 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2166 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2167 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2167 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-2167 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 64764-119 | Colcrys | Colchicine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-119 | Colcrys | Colchicine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-119 | Colcrys | Colchicine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-119 | Colcrys | Colchicine | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 66993-165 | Colchicine | Colchicine | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 67296-1708 | Colchicine | Colchicine | RedPharm Drug, Inc. | NDA AUTHORIZED GENERIC | Current |
| 67296-1708 | Colchicine | Colchicine | RedPharm Drug, Inc. | NDA AUTHORIZED GENERIC | Current |
| 71205-310 | Colchicine | Colchicine | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 71205-310 | Colchicine | Colchicine | Proficient Rx LP | NDA AUTHORIZED GENERIC | Current |
| 71335-1802 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-1802 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 72189-249 | COLCHICINE | COLCHICINE | direct rx | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63078 | SUPPL | 2020-05-18 |
| 63077 | SUPPL | 2020-05-18 |
| 63025 | SUPPL | 2020-05-15 |
| 46116 | SUPPL | 2016-12-09 |
| 17287 | SUPPL | 2015-12-31 |
| 7286 | SUPPL | 2015-12-18 |
| 38615 | SUPPL | 2014-08-15 |
| 29641 | SUPPL | 2014-08-15 |
| 38614 | SUPPL | 2011-07-25 |
| 29640 | SUPPL | 2011-07-25 |
| 17286 | SUPPL | 2011-07-25 |
| 7285 | SUPPL | 2011-07-25 |
| 17285 | SUPPL | 2010-05-07 |
| 29639 | SUPPL | 2010-05-06 |
| 44742 | ORIG | 2010-02-17 |
| 42498 | ORIG | 2010-02-17 |
| 29638 | ORIG | 2009-08-06 |
| 38613 | ORIG | 2009-07-30 |