Colestipol hydrochloride
Colestipol hydrochloride: 2 brands, 7 generics; first approved Jul 19, 1994; generic available.
Generic available: 7 ANDA applications approved.
Brand (NDA) products
- COLESTIDRLDPFIZERNDA 01756319954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/PACKET GRANULE ORAL Discontinued — 5GM/SCOOPFUL GRANULE ORAL Discontinued — 5GM/SCOOPFUL GRANULE ORAL Rx — 5GM/PACKET GRANULE ORAL Rx — - COLESTIDRLDPFIZERNDA 0202221994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB
Generic (ANDA) products (7)
- COLESTIPOL HYDROCHLORIDEMACLEODS PHARMSANDA 2200122025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - COLESTIPOL HYDROCHLORIDERICONPHARMA LLCANDA 2174622024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - COLESTIPOL HYDROCHLORIDEEDENBRIDGE PHARMSANDA 2176672024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - COLESTIPOL HYDROCHLORIDEANI PHARMSANDA 2165172023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - COLESTIPOL HYDROCHLORIDEZYDUS PHARMSANDA 2152232022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - COLESTIPOL HYDROCHLORIDERSIMPAX LABSANDA 0775102006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - COLESTIPOL HYDROCHLORIDEIMPAX LABSANDA 07727720062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/SCOOPFUL GRANULE ORAL Discontinued — 5GM/PACKET GRANULE ORAL Discontinued —
Listed patents
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
Approvals span 1994–2025 across 9 FDA applications.
Colestipol 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.
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