Application 022362

Type: NDA
Sponsor: DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WELCHOL	COLESEVELAM HYDROCHLORIDE	FOR SUSPENSION;ORAL	1.875GM/PACKET	Yes	No
002	WELCHOL	COLESEVELAM HYDROCHLORIDE	FOR SUSPENSION;ORAL	3.75GM/PACKET	Yes	Yes

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

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
N022362-001	WELCHOL	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02
N022362-002	WELCHOL	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022362-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022362-001	WELCHOL	1.875GM/PACKET	FOR SUSPENSION / ORAL		RLD	2009-10-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022362-001	WELCHOL	1.875GM/PACKET	FOR SUSPENSION / ORAL		RLD	2009-10-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022362-001	WELCHOL	1.875GM/PACKET	FOR SUSPENSION / ORAL		RLD	2009-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022362-001	WELCHOL	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	2009-10-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022362-002	WELCHOL	3.75GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-10-02	`bb7c543d1eb4…`

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	N022362-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022362-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022362-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022362-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022362-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022362-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022362-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022362-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022362-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022362-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022362-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022362-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022362-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022362-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022362-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022362-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022362-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022362-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022362-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022362-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022362-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022362-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022362-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022362-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022362-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022362-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022362-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022362-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022362-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022362-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022362-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022362-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022362-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022362-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022362-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022362-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022362-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022362-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022362-002	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-001	7229613	2022-04-17	U-493		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-002	7229613	2022-04-17	U-493		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022362-001	7229613	2022-04-17	U-493		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022362-002	7229613	2022-04-17	U-493		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022362-001	7229613	2022-04-17	U-493		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022362-002	7229613	2022-04-17	U-493		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022362-001	7229613	2022-04-17	U-493		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022362-002	7229613	2022-04-17	U-493		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022362-001	7229613	2022-04-17	U-493		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022362-002	7229613	2022-04-17	U-493		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022362-001	7229613	2022-04-17	U-493		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022362-002	7229613	2022-04-17	U-493		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022362-001	7229613	2022-04-17	U-493		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022362-002	7229613	2022-04-17	U-493		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022362-001	7229613	2022-04-17	U-493		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022362-002	7229613	2022-04-17	U-493		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022362-001	7229613	2022-04-17	U-493		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022362-002	7229613	2022-04-17	U-493		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022362-001	7229613	2022-04-17	U-493		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022362-001	7229613*PED	2022-10-17		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022362-002	7229613	2022-04-17	U-493		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022362-002	7229613*PED	2022-10-17		Pediatric extension	`c0c555d07b60…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022362-001	M-232	2024-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022362-002	M-232	2024-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022362-001	M-232	2024-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022362-002	M-232	2024-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022362-001	M-232	2024-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022362-002	M-232	2024-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022362-001	M-232	2024-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022362-002	M-232	2024-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022362-001	M-232	2024-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022362-002	M-232	2024-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022362-001	M-232	2024-10-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022362-002	M-232	2024-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022362-001	M-232	2024-10-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022362-002	M-232	2024-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022362-001	M-232	2024-10-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022362-002	M-232	2024-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022362-001	M-232	2024-10-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022362-002	M-232	2024-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-001	M-232	2024-10-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022362-002	M-232	2024-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022362-001	M-232	2024-10-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022362-002	M-232	2024-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022362-001	M-232	2024-10-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022362-002	M-232	2024-10-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022362-001	M-232	2024-10-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022362-002	M-232	2024-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022362-001	M-232	2024-10-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022362-002	M-232	2024-10-20	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022362-001	M-232	2024-10-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022362-002	M-232	2024-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022362-001	M-232	2024-10-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022362-002	M-232	2024-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022362-001	M-232	2024-10-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022362-002	M-232	2024-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022362-001	M-232	2024-10-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022362-002	M-232	2024-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022362-001	M-232	2024-10-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022362-002	M-232	2024-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022362-001	M-232	2024-10-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022362-002	M-232	2024-10-20	`a67488948f0b…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	Bryant Ranch Prepack	dbed6967-b261-44a1-bee4-638810e2efe9	2026-05-26	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Bionpharma Inc.	4aa52225-9214-59dc-e063-6294a90a5f75	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	845b8661-0aa9-418f-a496-df3d7a3130ff	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Glenmark Pharmaceuticals Inc.,USA	2e736dd4-bb64-4f93-9821-7c24ea7d38ec	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Golden State Medical Supply, Inc.	c7058806-ad4f-6d5f-e053-2a95a90a35e8	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	American Health Packaging	87bf6310-cfc4-4cb4-966e-8561b3880e36	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	0f235408-e28d-4cce-b7f1-66bbe0e4534c	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	b48a7426-b513-4790-99a4-4f07d83318d7	2025-07-16	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Macleods Pharmaceuticals Limited	c2075dd1-e33c-4438-95f8-1897f0e1f61a	2025-05-05	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Bionpharma Inc.	a2c5e881-2901-4f90-95cc-74930569e51e	2025-03-19	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	67820d4f-0cfb-43ca-8974-08dffe474983	2024-11-18	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	79af88a5-b873-499b-a9a4-fc39624820fe	2024-11-18	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	f5306376-e7f2-44ad-8250-635b95428a7c	2024-10-29	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	Cranbury Pharmaceuticals, LLC	5e50cc0c-03bc-444b-9d15-ea112bc0f91c	2024-07-31	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	Bryant Ranch Prepack	652fbd7b-2702-4db6-8691-be93c61bd9d6	2024-07-25	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	0127afae-8d8d-43f2-97f9-4f99f6947e81	2023-12-28	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	A-S Medication Solutions	40d66c9d-ff51-4353-8133-ae3a8eb4f713	2023-12-28	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam Hydrochloride	COLESEVELAM HYDROCHLORIDE	Dr.Reddys Laboratories Inc	28701657-640a-67d6-e56f-cf5c672c6e2a	2023-06-30	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	Ascend Laboratories, LLC	dfce5bc5-58fc-4fe5-b5c0-7a8026ee2b96	2023-02-16	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochloride	COLESEVELAM HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	f33fbf30-2486-49a7-bbe8-0ddfb4b9b786	2022-10-18	Warnings, Adverse reactions	Name fallback generic name: COLESEVELAM HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0880	Welchol	colesevelam hydrochloride	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0880	Welchol	colesevelam hydrochloride	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0935	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0935	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0935	COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	NDA	Current
21695-779	Welchol	colesevelam hydrochloride	Rebel Distributors Corp	NDA	Current
51660-995	Colesevelam hydrochloride	colesevelam hydrochloride	Ohm Laboratories, Inc.	NDA	Current
51660-995	Colesevelam hydrochloride	colesevelam hydrochloride	Ohm Laboratories, Inc.	NDA	Current
51660-995	Colesevelam hydrochloride	colesevelam hydrochloride	Ohm Laboratories, Inc.	NDA	Current
51660-995	Colesevelam hydrochloride	colesevelam hydrochloride	Ohm Laboratories, Inc.	NDA	Current
51660-995	Colesevelam hydrochloride	colesevelam hydrochloride	Ohm Laboratories, Inc.	NDA	Current
65597-902	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-902	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-902	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-902	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-902	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-902	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-902	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-902	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-903	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-903	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-903	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-903	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69060	SUPPL	2021-10-21
69051	SUPPL	2021-10-21
64146	SUPPL	2020-07-30
64134	SUPPL	2020-07-30
62962	SUPPL	2020-05-13
62956	SUPPL	2020-05-13
58838	SUPPL	2019-05-23
58831	SUPPL	2019-05-22
58494	SUPPL	2019-05-01
58290	SUPPL	2019-04-11
57310	SUPPL	2019-01-22
57242	SUPPL	2019-01-17
29652	SUPPL	2014-01-23
17294	SUPPL	2014-01-23
38623	SUPPL	2013-07-02
38622	SUPPL	2013-07-02
38621	SUPPL	2013-07-02
29651	SUPPL	2013-07-02
29650	SUPPL	2013-07-02
29649	SUPPL	2013-07-02
38620	SUPPL	2012-07-13
29648	SUPPL	2012-07-13
29647	SUPPL	2012-01-17
17293	SUPPL	2012-01-06
29646	SUPPL	2011-07-19
17292	SUPPL	2011-07-18
38619	SUPPL	2010-09-20
29645	SUPPL	2010-09-16
42499	ORIG	2010-03-31
24289	ORIG	2010-03-31
7294	ORIG	2009-10-26
17291	ORIG	2009-10-07
51493	ORIG	2007-04-02
51490	ORIG	2006-03-28
51487	ORIG	2006-01-19
51485	ORIG	2004-08-31