Application 209038

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	TABLET;ORAL	625MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209038-001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB		2018-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209038-001	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
2026-08-18 06:07:40	2026-07	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209038-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-10-05	`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
2026-08-18 06:07:40	2026-07	A209038-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209038-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209038-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209038-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209038-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209038-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209038-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209038-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209038-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209038-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209038-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209038-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209038-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209038-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209038-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209038-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209038-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209038-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209038-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209038-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209038-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209038-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209038-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209038-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209038-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209038-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209038-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209038-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209038-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209038-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209038-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209038-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209038-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209038-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209038-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209038-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209038-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209038-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209038-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209038-001	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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colesevelam HCL	COLESEVELAM HCL	Bryant Ranch Prepack	5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038 ndc (product): 63629-8767
Colesevelam HCL	COLESEVELAM HCL	Ascend Laboratories, LLC	4ffd02a3-86b8-4af7-b539-aa32e38c6b12	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038 ndc (product): 67877-506
Colesevelam HCL	COLESEVELAM HCL	A-S Medication Solutions	5eb26657-09cf-4229-a567-1395b58bba6b	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038 ndc (product): 50090-4371
Colesevelam HCL	COLESEVELAM HCL	A-S Medication Solutions	62ea3a03-5cd0-4adc-8464-c7d8b00cd0de	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038
Colesevelam HCL	COLESEVELAM HCL	Bryant Ranch Prepack	22cf31e6-59fa-40db-a181-2a12afc3af43	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038
Colesevelam HCL	COLESEVELAM HCL	PD-Rx Pharmaceuticals, Inc.	66a0f44e-3e68-4a67-a3d0-21a0bf99c9cb	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038
Colesevelam HCL	COLESEVELAM HCL	Bryant Ranch Prepack	ffac398c-3eb7-482a-80ce-0ad2cbd2bdca	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209038 application number: ANDA209038

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4371	Colesevelam HCL	Colesevelam HCL	A-S Medication Solutions	ANDA	Current
50090-4371	Colesevelam HCL	Colesevelam HCL	A-S Medication Solutions	ANDA	Current
50090-4371	Colesevelam HCL	Colesevelam HCL	A-S Medication Solutions	ANDA	Current
63629-8767	Colesevelam HCL	Colesevelam HCL	Bryant Ranch Prepack	ANDA	Current
63629-8767	Colesevelam HCL	Colesevelam HCL	Bryant Ranch Prepack	ANDA	Current
63629-8767	Colesevelam HCL	Colesevelam HCL	Bryant Ranch Prepack	ANDA	Current
67877-506	Colesevelam HCL	Colesevelam HCL	Ascend Laboratories, LLC	ANDA	Current
67877-506	Colesevelam HCL	Colesevelam HCL	Ascend Laboratories, LLC	ANDA	Current
67877-506	Colesevelam HCL	Colesevelam HCL	Ascend Laboratories, LLC	ANDA	Current
67877-506	Colesevelam HCL	Colesevelam HCL	Ascend Laboratories, LLC	ANDA	Current