Home Applications 215727 Application 215727
Type NDA
Sponsor AGEPHA PHARMA FZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LODOCO COLCHICINE TABLET;ORAL 0.5MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table 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# Current patent rows page 1 of 1 · 14 matching rows.
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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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# Patent history page 1 of 7 · 254 observed states.
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LODOCO COLCHICINE TABLETS 0.5 MG AGEPHA Pharma USA, LLC ff06d68f-d65f-d097-e053-6294a90a7e5f 2026-08-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 215727 application number: NDA215727
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 78996 ORIG 2024-07-09 74547 ORIG 2023-06-20 74544 ORIG 2023-06-20