FDA Orange Book · active-ingredient family
Colesevelam hydrochloride
Colesevelam hydrochloride: 4 brands, 18 generics; first approved May 26, 2000; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
18
Listed patents
0
Presentations
25
Brand (NDA) products
Originator applications
- WELCHOLRLDCOSETTENDA 2108952019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75GM BAR, CHEWABLE ORAL Discontinued — - WELCHOLRLDCOSETTENDA 02236220092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.875GM/PACKET FOR SUSPENSION ORAL Discontinued — 3.75GM/PACKET FOR SUSPENSION ORAL Rx AB - COSETTENDA 0211762000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COSETTENDA 0211412000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE ORAL Discontinued —
Generic (ANDA) products (18)
Abbreviated applications
- COLESEVELAM HYDROCHLORIDEMACLEODS PHARMS LTDANDA 2048932025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Discontinued — - COLESEVELAM HYDROCHLORIDEIMPAXANDA 2128862023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75GM/PACKET FOR SUSPENSION ORAL Discontinued — - COLESEVELAM HYDROCHLORIDEUNITED RES LABSANDA 2134562022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Discontinued — - COLESEVELAM HYDROCHLORIDEBEIJING TIDE PHARMANDA 2060362021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COLESEVELAM HYDROCHLORIDECHARTWELL RXANDA 2013542020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Discontinued — - COLESEVELAM HYDROCHLORIDEINVENTIAANDA 2120502020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COLESEVELAM HYDROCHLORIDEWATSON LABS INCANDA 2008302020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Discontinued — - COLESEVELAM HYDROCHLORIDEWATSON LABS INCANDA 20217820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.875GM/PACKET FOR SUSPENSION ORAL Discontinued — 3.75GM/PACKET FOR SUSPENSION ORAL Discontinued — - COLESEVELAM HYDROCHLORIDEZHEJIANG JINGXINANDA 2099462020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COLESEVELAM HYDROCHLORIDEINVAGEN PHARMSANDA 2126022020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Discontinued — - COLESEVELAM HYDROCHLORIDEZYDUS PHARMSANDA 2077652019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COLESEVELAM HYDROCHLORIDEBIONPHARMAANDA 2086702019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COLESEVELAM HYDROCHLORIDEALKEM LABS LTDANDA 2103162019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.75GM/PACKET FOR SUSPENSION ORAL Rx AB - COLESEVELAM HYDROCHLORIDEALKEM LABS LTDANDA 2090382018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COLESEVELAM HYDROCHLORIDEDR REDDYSANDA 2108892018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COLESEVELAM HYDROCHLORIDEGLENMARK PHARMS LTDANDA 20219020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.875GM/PACKET FOR SUSPENSION ORAL Rx — 3.75GM/PACKET FOR SUSPENSION ORAL Rx AB - COLESEVELAM HYDROCHLORIDEGLENMARK PHARMS LTDANDA 2034802018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB - COLESEVELAM HYDROCHLORIDEIMPAX LABS INCANDA 0916002018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 625MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
26 yr 7 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 2000–2025 across 22 FDA applications.
Brand (NDA) 418%
Generic (ANDA) 1882%
Colesevelam hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
