Application 209876

Type: ANDA
Sponsor: DR REDDYS

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
A209876-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209876-001	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	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`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	A209876-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209876-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209876-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209876-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209876-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209876-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209876-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209876-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209876-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209876-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209876-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209876-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209876-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209876-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209876-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209876-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209876-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209876-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209876-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209876-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209876-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209876-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209876-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209876-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209876-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209876-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209876-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209876-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209876-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209876-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209876-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209876-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209876-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209876-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209876-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209876-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209876-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209876-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209876-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209876-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
colchicine	COLCHICINE	REMEDYREPACK INC.	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209876 application number: ANDA209876
colchicine	COLCHICINE	Dr.Reddys Laboratories, Inc.	2cd5298e-43c6-a8dc-4467-9a3e1ade9307	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209876 application number: ANDA209876 ndc (product): 43598-372
colchicine	COLCHICINE	Proficient Rx LP	0f69b9c6-8c00-45e2-b950-34dc5ae62352	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209876 application number: ANDA209876 ndc (product): 71205-687
COLCHICINE	COLCHICINE	Direct Rx	d92b7189-78fd-693d-e053-2a95a90a7c73	2025-01-21		Exact identifier application applno (ANDA): 209876 application number: ANDA209876 ndc (product): 72189-331
colchicine	COLCHICINE	Bryant Ranch Prepack	14d4be16-d355-4baf-b4cd-4d97d4b2dca0	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209876 application number: ANDA209876 ndc (product): 71335-1738

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-372	colchicine	colchicine	Dr.Reddys Laboratories, Inc.	ANDA	Current
43598-372	colchicine	colchicine	Dr.Reddys Laboratories, Inc.	ANDA	Current
43598-372	colchicine	colchicine	Dr.Reddys Laboratories, Inc.	ANDA	Current
43598-372	colchicine	colchicine	Dr.Reddys Laboratories, Inc.	ANDA	Current
71205-687	colchicine	colchicine	Proficient Rx LP	ANDA	Current
71205-687	colchicine	colchicine	Proficient Rx LP	ANDA	Current
71335-1738	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
71335-1738	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
71335-1738	colchicine	colchicine	Bryant Ranch Prepack	ANDA	Current
72189-331	COLCHICINE	COLCHICINE	Direct Rx	ANDA	Current
72189-331	COLCHICINE	COLCHICINE	Direct Rx	ANDA	Current