Application 211250

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A211250-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211250-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211250-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211250-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211250-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211250-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211250-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211250-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211250-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211250-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211250-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211250-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211250-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211250-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211250-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211250-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211250-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211250-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211250-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211250-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211250-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211250-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211250-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211250-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211250-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211250-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211250-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211250-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211250-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211250-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211250-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211250-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211250-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211250-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211250-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211250-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211250-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211250-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211250-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211250-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211250-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211250-001	AB	1	`cb3db0bc1861…`

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 · 7 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	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	Bryant Ranch Prepack	5ae87893-a065-468e-b8da-f1db86afcaef	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250 ndc (product): 63629-8362
colchicine	COLCHICINE	Ascend Laboratories, LLC	a4284783-fea6-4af2-9a8d-79c929176c05	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250 ndc (product): 67877-589
colchicine	COLCHICINE	ST. MARY'S MEDICAL PARK PHARMACY	5102af58-15b1-1516-e063-6294a90a50e3	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	Bryant Ranch Prepack	8b78d6f7-714b-4e6c-b109-fbcb96d66633	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	NuCare Pharmaceuticals,Inc.	d010a735-1a20-23fe-e053-2995a90abe0f	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250 ndc (product): 68071-2567
colchicine	COLCHICINE	Bryant Ranch Prepack	11a62c34-db88-4a79-81a1-59b316d41d66	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250 ndc (product): 63629-8766

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-8362	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
63629-8362	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
63629-8362	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
63629-8362	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
63629-8766	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
63629-8766	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
63629-8766	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
67877-589	colchicine	colchicine	Ascend Laboratories, LLC	ANDA	Current
67877-589	colchicine	colchicine	Ascend Laboratories, LLC	ANDA	Current
67877-589	colchicine	colchicine	Ascend Laboratories, LLC	ANDA	Current
67877-589	colchicine	colchicine	Ascend Laboratories, LLC	ANDA	Current
68071-2567	colchicine	colchicine	NuCare Pharmaceuticals,Inc.	ANDA	Current
71335-1695	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
71335-1695	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
71335-1695	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
71335-1695	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
71335-1695	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
71335-1695	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current