Application 210895

Type: NDA
Sponsor: DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WELCHOL	COLESEVELAM HYDROCHLORIDE	BAR, CHEWABLE;ORAL	3.75GM	Yes	Yes

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
N210895-001	WELCHOL	COLESEVELAM HYDROCHLORIDE	3.75GM	BAR, CHEWABLE / ORAL		RLD	2019-04-03

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD, RS	2019-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD, RS	2019-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD, RS	2019-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD, RS	2019-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210895-001	WELCHOL	3.75GM	BAR, CHEWABLE / ORAL	RLD	2019-04-03	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210895-001	7229613	2022-04-17	U-2516	2019-05-02	`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 · 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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65597-208	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-208	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-208	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-209	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-209	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-209	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-210	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-210	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current
65597-210	Welchol	colesevelam hydrochloride	Daiichi Sankyo Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62963	SUPPL	2020-05-13
62958	SUPPL	2020-05-13
59903	ORIG	2019-09-03
58200	ORIG	2019-09-03
58211	ORIG	2019-04-04
64997	ORIG	1900-01-01
64996	ORIG	1900-01-01
62921	ORIG	1900-01-01