Application 204820
- Type
- NDA
- Sponsor
- HIKMA INTL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MITIGARE | COLCHICINE | CAPSULE;ORAL | 0.6MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204820-001 | MITIGARE | COLCHICINE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N204820-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | |
| N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | |
| N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | |
| N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | |
| N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 |
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 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | AB | RLD, RS | 2014-09-26 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N204820-001 | MITIGARE | 0.6MG | CAPSULE / ORAL | RLD, RS | 2014-09-26 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204820-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204820-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204820-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204820-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204820-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204820-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204820-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204820-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204820-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N204820-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204820-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204820-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204820-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N204820-001 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N204820-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N204820-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N204820-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204820-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204820-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204820-001 | AB | 1 | a67488948f0b… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204820-001 | AB | 1 | a50c72e98297… |
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 | N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204820-001 | 8927607 | 2033-08-22 | U-1020 | 2015-01-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204820-001 | 9399036 | 2033-08-22 | U-1020 | 2016-08-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204820-001 | 9555029 | 2033-08-22 | U-1020 | 2017-02-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204820-001 | 9675613 | 2033-08-22 | U-1020 | 2017-06-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204820-001 | 9789108 | 2033-08-22 | U-1020 | 2017-11-13 | 5bbf6a4d5a75… |
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 | Major Pharmaceuticals | 19486f52-1c7b-43b8-ba48-0d1a6389fedf | 2026-03-18 | Warnings, Adverse reactions | 204820 NDA204820 0904-6732 |
| Colchicine | COLCHICINE | American Health Packaging | 2f5e24de-3956-4724-a5d7-fe81dcb07f6e | 2025-05-15 | Warnings, Adverse reactions | 204820 NDA204820 60687-358 |
| Colchicine | COLCHICINE | Coupler LLC | 2cb88c93-54b8-a548-e063-6294a90a94e6 | 2025-03-26 | Warnings, Adverse reactions | 204820 NDA204820 |
| Colchicine | COLCHICINE | A-S Medication Solutions | 25307250-c16b-4467-9ad0-e6c752c576bd | 2024-06-05 | Warnings, Adverse reactions | 204820 NDA204820 50090-3465 |
| Colchicine | COLCHICINE | Hikma Pharmaceuticals USA Inc. | ee1583ac-c308-4beb-b602-9ecac4977026 | 2024-05-22 | Warnings, Adverse reactions | 204820 NDA204820 0143-3018 |
| MITIGARE | COLCHICINE | Hikma Specialty USA Inc. | cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2 | 2024-05-16 | Warnings, Adverse reactions | 204820 NDA204820 59467-318 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-3018 | Colchicine | Colchicine | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-3018 | Colchicine | Colchicine | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0143-3018 | Colchicine | Colchicine | West-Ward Pharmaceuticals Corp | NDA | Current |
| 0904-6732 | Colchicine | Colchicine | Major Pharmaceuticals | NDA | Current |
| 0904-6732 | Colchicine | Colchicine | Major Pharmaceuticals | NDA | Current |
| 50090-3465 | Colchicine | Colchicine | A-S Medication Solutions | NDA | Current |
| 50090-3465 | Colchicine | Colchicine | A-S Medication Solutions | NDA | Current |
| 59467-318 | MITIGARE | Colchicine | Hikma Specialty USA Inc. | NDA | Current |
| 59467-318 | MITIGARE | Colchicine | Hikma Specialty USA Inc. | NDA | Current |
| 59467-318 | MITIGARE | Colchicine | Hikma Americas, Inc. | NDA | Current |
| 60687-358 | Colchicine | Colchicine | American Health Packaging | NDA | Current |
| 60687-358 | Colchicine | Colchicine | American Health Packaging | NDA | Current |
| 60687-358 | Colchicine | Colchicine | American Health Packaging | NDA | Current |
| 63629-7422 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA | Current |
| 63629-7422 | Colchicine | Colchicine | Bryant Ranch Prepack | NDA | Current |