Application 204461

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COLCHICINE	COLCHICINE	TABLET;ORAL	0.6MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204461-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204461-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204461-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204461-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204461-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204461-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204461-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204461-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204461-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204461-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204461-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204461-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204461-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204461-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204461-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204461-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204461-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204461-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204461-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204461-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204461-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204461-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204461-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204461-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204461-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204461-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204461-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204461-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204461-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204461-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204461-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204461-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204461-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204461-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204461-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204461-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204461-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204461-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204461-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204461-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204461-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204461-001	AB	1	`a50c72e98297…`

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 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
colchicine	COLCHICINE	A-S Medication Solutions	5c1ceff7-8f00-48cc-8ea4-678106455ff1	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
colchicine	COLCHICINE	Bryant Ranch Prepack	5ae87893-a065-468e-b8da-f1db86afcaef	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
colchicine	COLCHICINE	Ascend Laboratories, LLC	a4284783-fea6-4af2-9a8d-79c929176c05	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	REMEDYREPACK INC.	f818ffe0-43df-4cc6-bc86-00b2c79b06fc	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Par Health USA, LLC	eb509994-6ecc-4599-b87a-98495fef6129	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
colchicine	COLCHICINE	REMEDYREPACK INC.	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	PD-Rx Pharmaceuticals, Inc.	68d4bf2b-8e2c-4621-aa08-463f43e253c3	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
colchicine	COLCHICINE	ST. MARY'S MEDICAL PARK PHARMACY	5102af58-15b1-1516-e063-6294a90a50e3	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Macleods Pharmaceuticals Limited	9111bbad-b020-44fb-b276-d7853e5acd2c	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Golden State Medical Supply, Inc.	ac12e420-9f29-018e-e053-2a95a90ab612	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	American Health Packaging	4b79a786-3f9e-4dad-aa66-bae5f299b966	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Major Pharmaceuticals	19486f52-1c7b-43b8-ba48-0d1a6389fedf	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Bryant Ranch Prepack	5cefec2e-1982-4417-8d99-5711231b3933	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Micro Labs Limited	efe34b7c-0e6e-4aeb-9718-cf9b8e19a302	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
COLCHICINE	COLCHICINE	Coupler LLC	472ec026-c755-ae02-e063-6394a90af0c6	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: COLCHICINE generic name: COLCHICINE
Colchicine	COLCHICINE	AvPAK	cc0e205a-697e-d47e-e053-2995a90a154e	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Chartwell RX, LLC	16d8e0f4-567d-4de1-ac25-6e2527f1d58e	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
colchicine	COLCHICINE	Bryant Ranch Prepack	8b78d6f7-714b-4e6c-b109-fbcb96d66633	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Bryant Ranch Prepack	d83c6ae4-a41c-4b14-94b3-2d93c9aa28d1	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
colchicine	COLCHICINE	Dr.Reddys Laboratories, Inc.	2cd5298e-43c6-a8dc-4467-9a3e1ade9307	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2562	Colchicine	Colchicine	Actavis Pharma, Inc.	ANDA	Current
0591-2562	Colchicine	Colchicine	Actavis Pharma, Inc.	ANDA	Current