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 44.

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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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#

Patent history page 1 of 7 · 268 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	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.

Matched openFDA labels page 1 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	Direct_Rx	5a0b4246-e7dd-29e5-e063-6294a90a2871	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	Golden State Medical Supply, Inc.	ac12e420-9f29-018e-e053-2a95a90ab612	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
colchicine	COLCHICINE	A-S Medication Solutions	5c1ceff7-8f00-48cc-8ea4-678106455ff1	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
colchicine	COLCHICINE	Bryant Ranch Prepack	5ae87893-a065-468e-b8da-f1db86afcaef	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
colchicine	COLCHICINE	Ascend Laboratories, LLC	a4284783-fea6-4af2-9a8d-79c929176c05	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	REMEDYREPACK INC.	f818ffe0-43df-4cc6-bc86-00b2c79b06fc	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	Par Health USA, LLC	eb509994-6ecc-4599-b87a-98495fef6129	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
colchicine	COLCHICINE	REMEDYREPACK INC.	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	PD-Rx Pharmaceuticals, Inc.	68d4bf2b-8e2c-4621-aa08-463f43e253c3	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
colchicine	COLCHICINE	ST. MARY'S MEDICAL PARK PHARMACY	5102af58-15b1-1516-e063-6294a90a50e3	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	Macleods Pharmaceuticals Limited	9111bbad-b020-44fb-b276-d7853e5acd2c	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	American Health Packaging	4b79a786-3f9e-4dad-aa66-bae5f299b966	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	Major Pharmaceuticals	19486f52-1c7b-43b8-ba48-0d1a6389fedf	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	Bryant Ranch Prepack	5cefec2e-1982-4417-8d99-5711231b3933	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	Micro Labs Limited	efe34b7c-0e6e-4aeb-9718-cf9b8e19a302	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
COLCHICINE	COLCHICINE	Coupler LLC	472ec026-c755-ae02-e063-6394a90af0c6	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	AvPAK	cc0e205a-697e-d47e-e053-2995a90a154e	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	Chartwell RX, LLC	16d8e0f4-567d-4de1-ac25-6e2527f1d58e	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
colchicine	COLCHICINE	Bryant Ranch Prepack	8b78d6f7-714b-4e6c-b109-fbcb96d66633	2025-11-03	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
Colchicine	COLCHICINE	Bryant Ranch Prepack	d83c6ae4-a41c-4b14-94b3-2d93c9aa28d1	2025-09-26	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE

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