FDA.reportPublic FDA data

Application 210895

Type
NDA
Sponsor
DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELCHOLCOLESEVELAM HYDROCHLORIDEBAR, CHEWABLE;ORAL3.75GMYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210895-001WELCHOLCOLESEVELAM HYDROCHLORIDE3.75GMBAR, CHEWABLE / ORALRLD2019-04-03

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N210895-001WELCHOL3.75GMBAR, CHEWABLE / ORALRLD2019-04-03a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEBryant Ranch Prepackdbed6967-b261-44a1-bee4-638810e2efe92026-05-26Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEBionpharma Inc.4aa52225-9214-59dc-e063-6294a90a5f752026-02-12Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA845b8661-0aa9-418f-a496-df3d7a3130ff2026-01-29Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEGlenmark Pharmaceuticals Inc.,USA2e736dd4-bb64-4f93-9821-7c24ea7d38ec2026-01-28Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEGolden State Medical Supply, Inc.c7058806-ad4f-6d5f-e053-2a95a90a35e82025-12-10Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmerican Health Packaging87bf6310-cfc4-4cb4-966e-8561b3880e362025-12-05Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutions0f235408-e28d-4cce-b7f1-66bbe0e4534c2025-07-17Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutionsb48a7426-b513-4790-99a4-4f07d83318d72025-07-16Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEMacleods Pharmaceuticals Limitedc2075dd1-e33c-4438-95f8-1897f0e1f61a2025-05-05Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEBionpharma Inc.a2c5e881-2901-4f90-95cc-74930569e51e2025-03-19Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutions67820d4f-0cfb-43ca-8974-08dffe4749832024-11-18Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutions79af88a5-b873-499b-a9a4-fc39624820fe2024-11-18Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCf5306376-e7f2-44ad-8250-635b95428a7c2024-10-29Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDECranbury Pharmaceuticals, LLC5e50cc0c-03bc-444b-9d15-ea112bc0f91c2024-07-31Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEBryant Ranch Prepack652fbd7b-2702-4db6-8691-be93c61bd9d62024-07-25Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEA-S Medication Solutions0127afae-8d8d-43f2-97f9-4f99f6947e812023-12-28Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEA-S Medication Solutions40d66c9d-ff51-4353-8133-ae3a8eb4f7132023-12-28Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEDr.Reddys Laboratories Inc28701657-640a-67d6-e56f-cf5c672c6e2a2023-06-30Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEAscend Laboratories, LLCdfce5bc5-58fc-4fe5-b5c0-7a8026ee2b962023-02-16Warnings, Adverse reactionsName fallback
generic name: COLESEVELAM HYDROCHLORIDE
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCf33fbf30-2486-49a7-bbe8-0ddfb4b9b7862022-10-18Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62963SUPPL2020-05-13
62958SUPPL2020-05-13
59903ORIG2019-09-03
58200ORIG2019-09-03
58211ORIG2019-04-04
64997ORIG1900-01-01
64996ORIG1900-01-01
62921ORIG1900-01-01