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 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
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.

Product history page 1 of 2 · 42 observed 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
2026-09-14 22:38:34	2026-08	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204461-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204461-001	AB	1	`caaa826d4ba7…`
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…`

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 2 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback brand name: colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Par Health USA, LLC	72984aa2-6df9-4460-9926-399ffed30e36	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Aurobindo Pharma Limited	a1ff526f-e89f-4dca-80b6-653d6bdfd895	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Aurobindo Pharma Limited	dd93a40f-92ab-47ac-9083-b8a7a0b18ad6	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
colchicine	COLCHICINE	Proficient Rx LP	0f69b9c6-8c00-45e2-b950-34dc5ae62352	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Granules Pharmaceutical Inc.	16d49c45-5b0a-a7fa-e063-6294a90a7320	2025-06-23	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	American Health Packaging	2f5e24de-3956-4724-a5d7-fe81dcb07f6e	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Amneal Pharmaceuticals LLC	7daef7e2-888d-4116-81a9-2c02b9ef97ef	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Coupler LLC	2cb88c93-54b8-a548-e063-6294a90a94e6	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Major Pharmaceuticals	9e7c8f65-4722-4187-9014-8fa81eb5681e	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
COLCHICINE	COLCHICINE	Direct Rx	d92b7189-78fd-693d-e053-2a95a90a7c73	2025-01-21		Name fallback brand name: COLCHICINE generic name: COLCHICINE
COLCHICINE	COLCHICINE	direct rx	c7d013b7-0a67-0953-e053-2a95a90ac47c	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: COLCHICINE generic name: COLCHICINE
colchicine	COLCHICINE	NuCare Pharmaceuticals,Inc.	d010a735-1a20-23fe-e053-2995a90abe0f	2025-01-10	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Zydus Lifesciences Limited	cd720ef0-1cb8-40bc-a657-10accb6542b6	2024-11-26		Name fallback brand name: Colchicine generic name: COLCHICINE
Gloperba	COLCHICINE	Scilex Pharmaceuticals Inc.	467cd83f-d695-4040-9434-10e80b4271da	2024-11-01	Warnings, Adverse reactions	Name fallback generic name: COLCHICINE
colchicine	COLCHICINE	Bryant Ranch Prepack	11a62c34-db88-4a79-81a1-59b316d41d66	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	A-S Medication Solutions	7b6abc78-b2d6-4949-b109-4c857f37ef12	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
COLCHICINE	COLCHICINE	Camber Pharmaceuticals, Inc.	b280f0dc-b24c-4606-aaf4-0673070d5b64	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: COLCHICINE generic name: COLCHICINE
Colchicine	COLCHICINE	A-S Medication Solutions	25307250-c16b-4467-9ad0-e6c752c576bd	2024-06-05	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE
Colchicine	COLCHICINE	Hikma Pharmaceuticals USA Inc.	ee1583ac-c308-4beb-b602-9ecac4977026	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Colchicine generic name: COLCHICINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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