Application 091600

Type: ANDA
Sponsor: IMPAX LABS INC

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 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
A091600-001	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB		2018-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091600-001	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	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091600-001	COLESEVELAM HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2018-05-16	`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	A091600-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091600-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091600-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091600-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091600-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091600-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091600-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091600-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091600-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091600-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091600-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091600-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091600-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091600-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091600-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091600-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091600-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091600-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091600-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091600-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091600-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091600-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091600-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091600-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091600-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091600-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091600-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091600-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091600-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091600-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091600-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091600-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091600-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091600-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091600-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091600-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091600-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091600-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091600-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091600-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	American Health Packaging	87bf6310-cfc4-4cb4-966e-8561b3880e36	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091600 application number: ANDA091600 ndc (product): 60687-385
Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	f5306376-e7f2-44ad-8250-635b95428a7c	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091600 application number: ANDA091600 ndc (product): 0115-1320

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1320	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1320	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1320	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1320	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1320	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1320	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1320	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Impax Generics	ANDA	Current
42291-147	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	AvKARE, Inc.	ANDA	Current
42291-147	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	AvKARE, Inc.	ANDA	Current
42291-147	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	AvKARE	ANDA	Current
60687-385	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	American Health Packaging	ANDA	Current
60687-385	Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	American Health Packaging	ANDA	Current
60687-385	Colesevelam Hydrochloride	Colesevelam Hydrochloride	American Health Packaging	ANDA	Current
60687-385	Colesevelam Hydrochloride	Colesevelam Hydrochloride	American Health Packaging	ANDA	Current
60687-385	Colesevelam Hydrochloride	Colesevelam Hydrochloride	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54441	ORIG	2018-06-05