Application 211519

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COLCHICINE	COLCHICINE	TABLET;ORAL	0.6MG	No	No
002	COLCHICINE	COLCHICINE	TABLET;ORAL	0.3MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211519-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-02-19
A211519-002	COLCHICINE	COLCHICINE	0.3MG	TABLET / ORAL			2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211519-001	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 · 78 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	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-02-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`87673890dc5c…`

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	A211519-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211519-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211519-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211519-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211519-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211519-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211519-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211519-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211519-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211519-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211519-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211519-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211519-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211519-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211519-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211519-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211519-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211519-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211519-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211519-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211519-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211519-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211519-001	AB	1	`c0c555d07b60…`
2019-07-19 19:46 UTC	2019-07	A211519-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211519-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211519-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211519-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211519-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211519-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211519-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211519-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211519-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211519-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211519-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211519-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211519-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211519-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211519-001	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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	Zydus Lifesciences Limited	cd720ef0-1cb8-40bc-a657-10accb6542b6	2024-11-26		Exact identifier application applno (ANDA): 211519 application number: ANDA211519 ndc (product): 70771-1396 ndc (product): 70771-1590
Colchicine	COLCHICINE	A-S Medication Solutions	7b6abc78-b2d6-4949-b109-4c857f37ef12	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211519 application number: ANDA211519
Colchicine	COLCHICINE	Northstar Rx LLC.	94bee24f-d846-4344-bc42-b2eae6b433ba	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211519 application number: ANDA211519 ndc (product): 16714-039
Colchicine	COLCHICINE	Zydus Pharmaceuticals USA Inc.	c8fd7034-5ca2-4a58-b303-7f78ffdf8d76	2022-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211519 application number: ANDA211519 ndc (product): 70710-1571 ndc (product): 70710-1351

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-039	Colchicine	Colchicine	Northstar Rx LLC.	ANDA	Current
16714-039	Colchicine	Colchicine	Northstar Rx LLC.	ANDA	Current
70710-1351	Colchicine	Colchicine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1351	Colchicine	Colchicine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1351	Colchicine	Colchicine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1571	Colchicine	Colchicine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1571	Colchicine	Colchicine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1396	Colchicine	Colchicine	Cadila Healthcare Limited	ANDA	Current
70771-1396	Colchicine	Colchicine	Zydus Lifesciences Limited	ANDA	Current
70771-1396	Colchicine	Colchicine	Cadila Healthcare Limited	ANDA	Current
70771-1590	Colchicine	Colchicine	Cadila Healthcare Limited	ANDA	Current
70771-1590	Colchicine	Colchicine	Zydus Lifesciences Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63029	SUPPL	2020-05-15