Application 215727
- Type
- NDA
- Sponsor
- AGEPHA PHARMA FZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LODOCO | COLCHICINE | TABLET;ORAL | 0.5MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215727-001 | LODOCO | COLCHICINE | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215727-001 | 10206891 | 2033-11-01 | U-3641 | 2023-06-29 | |
| N215727-001 | 10265281 | 2033-11-01 | U-3639 | 2023-06-29 | |
| N215727-001 | 10842762 | 2033-11-01 | U-3640 | 2023-06-29 | |
| N215727-001 | 11026899 | 2033-11-01 | U-3639 | 2023-06-29 | |
| N215727-001 | 11026900 | 2033-11-01 | U-3639 | 2023-06-29 | |
| N215727-001 | 11026901 | 2033-11-01 | U-3638 | 2023-06-29 | |
| N215727-001 | 11944594 | 2033-11-01 | U-3864 | 2024-04-03 | |
| N215727-001 | 11944595 | 2033-11-01 | U-3867 | 2024-04-05 | |
| N215727-001 | 11944595 | 2033-11-01 | U-3868 | 2024-04-05 | |
| N215727-001 | 12233035 | 2033-11-01 | U-4132 | 2025-02-27 | |
| N215727-001 | 12280025 | 2033-11-01 | U-4168 | 2025-04-25 | |
| N215727-001 | 12364675 | 2033-11-01 | U-3639 | 2025-07-23 | |
| N215727-001 | 9744144 | 2033-11-01 | U-3643 | 2023-06-29 | |
| N215727-001 | 10130585 | 2034-05-09 | U-3642 | 2023-06-29 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | a67488948f0b… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215727-001 | LODOCO | 0.5MG | TABLET / ORAL | RLD, RS | 2023-06-16 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 10206891 | 2033-11-01 | U-3641 | 2023-06-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 10265281 | 2033-11-01 | U-3639 | 2023-06-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 10842762 | 2033-11-01 | U-3640 | 2023-06-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 11026899 | 2033-11-01 | U-3639 | 2023-06-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 11026900 | 2033-11-01 | U-3639 | 2023-06-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 11026901 | 2033-11-01 | U-3638 | 2023-06-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 11944594 | 2033-11-01 | U-3864 | 2024-04-03 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 11944595 | 2033-11-01 | U-3867 | 2024-04-05 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 11944595 | 2033-11-01 | U-3868 | 2024-04-05 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 12233035 | 2033-11-01 | U-4132 | 2025-02-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 12280025 | 2033-11-01 | U-4168 | 2025-04-25 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 12364675 | 2033-11-01 | U-3639 | 2025-07-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 9744144 | 2033-11-01 | U-3643 | 2023-06-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N215727-001 | 10130585 | 2034-05-09 | U-3642 | 2023-06-29 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 10206891 | 2033-11-01 | U-3641 | 2023-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 10265281 | 2033-11-01 | U-3639 | 2023-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 10842762 | 2033-11-01 | U-3640 | 2023-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 11026899 | 2033-11-01 | U-3639 | 2023-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 11026900 | 2033-11-01 | U-3639 | 2023-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 11026901 | 2033-11-01 | U-3638 | 2023-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 11944594 | 2033-11-01 | U-3864 | 2024-04-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 11944595 | 2033-11-01 | U-3867 | 2024-04-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 11944595 | 2033-11-01 | U-3868 | 2024-04-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 12233035 | 2033-11-01 | U-4132 | 2025-02-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 12280025 | 2033-11-01 | U-4168 | 2025-04-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 12364675 | 2033-11-01 | U-3639 | 2025-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 9744144 | 2033-11-01 | U-3643 | 2023-06-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215727-001 | 10130585 | 2034-05-09 | U-3642 | 2023-06-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 10206891 | 2033-11-01 | U-3641 | 2023-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 10265281 | 2033-11-01 | U-3639 | 2023-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 10842762 | 2033-11-01 | U-3640 | 2023-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 11026899 | 2033-11-01 | U-3639 | 2023-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 11026900 | 2033-11-01 | U-3639 | 2023-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 11026901 | 2033-11-01 | U-3638 | 2023-06-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 11944594 | 2033-11-01 | U-3864 | 2024-04-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 11944595 | 2033-11-01 | U-3867 | 2024-04-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 11944595 | 2033-11-01 | U-3868 | 2024-04-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 12233035 | 2033-11-01 | U-4132 | 2025-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 12280025 | 2033-11-01 | U-4168 | 2025-04-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215727-001 | 12364675 | 2033-11-01 | U-3639 | 2025-07-23 | caaa826d4ba7… |
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 | Dr.Reddys Laboratories, Inc. | 2cd5298e-43c6-a8dc-4467-9a3e1ade9307 | 2025-09-01 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Par Health USA, LLC | 72984aa2-6df9-4460-9926-399ffed30e36 | 2025-08-20 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Aurobindo Pharma Limited | a1ff526f-e89f-4dca-80b6-653d6bdfd895 | 2025-07-22 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Aurobindo Pharma Limited | dd93a40f-92ab-47ac-9083-b8a7a0b18ad6 | 2025-07-22 | Warnings, Adverse reactions | COLCHICINE |
| colchicine | COLCHICINE | Proficient Rx LP | 0f69b9c6-8c00-45e2-b950-34dc5ae62352 | 2025-07-01 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Granules Pharmaceutical Inc. | 16d49c45-5b0a-a7fa-e063-6294a90a7320 | 2025-06-23 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | American Health Packaging | 2f5e24de-3956-4724-a5d7-fe81dcb07f6e | 2025-05-15 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Amneal Pharmaceuticals LLC | 7daef7e2-888d-4116-81a9-2c02b9ef97ef | 2025-03-27 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Coupler LLC | 2cb88c93-54b8-a548-e063-6294a90a94e6 | 2025-03-26 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Major Pharmaceuticals | 9e7c8f65-4722-4187-9014-8fa81eb5681e | 2025-02-03 | Warnings, Adverse reactions | COLCHICINE |
| COLCHICINE | COLCHICINE | Direct Rx | d92b7189-78fd-693d-e053-2a95a90a7c73 | 2025-01-21 | COLCHICINE | |
| COLCHICINE | COLCHICINE | direct rx | c7d013b7-0a67-0953-e053-2a95a90ac47c | 2025-01-20 | Warnings, Adverse reactions | COLCHICINE |
| colchicine | COLCHICINE | NuCare Pharmaceuticals,Inc. | d010a735-1a20-23fe-e053-2995a90abe0f | 2025-01-10 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Zydus Lifesciences Limited | cd720ef0-1cb8-40bc-a657-10accb6542b6 | 2024-11-26 | COLCHICINE | |
| Gloperba | COLCHICINE | Scilex Pharmaceuticals Inc. | 467cd83f-d695-4040-9434-10e80b4271da | 2024-11-01 | Warnings, Adverse reactions | COLCHICINE |
| colchicine | COLCHICINE | Bryant Ranch Prepack | 11a62c34-db88-4a79-81a1-59b316d41d66 | 2024-08-14 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | A-S Medication Solutions | 7b6abc78-b2d6-4949-b109-4c857f37ef12 | 2024-08-05 | Warnings, Adverse reactions | COLCHICINE |
| COLCHICINE | COLCHICINE | Camber Pharmaceuticals, Inc. | b280f0dc-b24c-4606-aaf4-0673070d5b64 | 2024-07-19 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | A-S Medication Solutions | 25307250-c16b-4467-9ad0-e6c752c576bd | 2024-06-05 | Warnings, Adverse reactions | COLCHICINE |
| Colchicine | COLCHICINE | Bryant Ranch Prepack | a15538ee-d1eb-4118-97c3-53748cea012a | 2024-05-22 | Warnings, Adverse reactions | COLCHICINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.