FDA Orange Book · active-ingredient family
Cholestyramine
Cholestyramine: 2 brands, 26 generics; first approved May 26, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
26
Listed patents
0
Presentations
52
Brand (NDA) products
Originator applications
- BRISTOL MYERSNDA 01966919882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Discontinued — EQ 4GM RESIN/SCOOPFUL POWDER ORAL Discontinued — - QUESTRANRLDBRISTOL MYERSNDA 016640—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Discontinued — EQ 4GM RESIN/SCOOPFUL POWDER ORAL Discontinued —
Generic (ANDA) products (26)
Abbreviated applications
- CHOLESTYRAMINEMICRO LABSANDA 2193182026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB - CHOLESTYRAMINEMACLEODS PHARMS LTDANDA 20729420242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - MACLEODS PHARMS LTDANDA 20910920242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/SCOOPFUL POWDER ORAL Discontinued — EQ 4GM RESIN/PACKET POWDER ORAL Discontinued — - CHOLESTYRAMINEAIPING PHARM INCANDA 21487720222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - CHOLESTYRAMINEALKEM LABS LTDANDA 21185620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - ALKEM LABS LTDANDA 21179920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - CHOLESTYRAMINEPHARMOBEDIENTANDA 20959720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - PHARMOBEDIENT CNSLTGANDA 20959920202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - CHOLESTYRAMINEAJANTA PHARMA LTDANDA 21111920202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - CHOLESTYRAMINEZYDUS PHARMSANDA 2029012018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - ZYDUS PHARMSANDA 20290220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB EQ 4GM RESIN/PACKET POWDER ORAL Rx AB - CHOLESTYRAMINEPH HEALTHANDA 07720420052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - PH HEALTHANDA 07720320052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - TEVA PHARMSANDA 07455519982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Discontinued — EQ 4GM RESIN/SCOOPFUL POWDER ORAL Discontinued — - CHOLESTYRAMINETEVAANDA 07434719982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Discontinued — EQ 4GM RESIN/SCOOPFUL POWDER ORAL Discontinued — - TEVAANDA 07434819982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Discontinued — EQ 4GM RESIN/SCOOPFUL POWDER ORAL Discontinued — - CHOLESTYRAMINEIVAX SUB TEVA PHARMSANDA 07477119972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Discontinued — EQ 4GM RESIN/SCOOPFUL POWDER ORAL Discontinued — - CHOLESTYRAMINEANI PHARMSANDA 07455419962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Discontinued — EQ 4GM RESIN/SCOOPFUL POWDER ORAL Discontinued — - CHOLESTYRAMINERSEPIC PHARMA LLCANDA 07455719962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - EPIC PHARMA LLCANDA 07455819962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - CHARTWELL RXANDA 07456119962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - CHARTWELL RXANDA 07456219962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - AIPING PHARM INCANDA 07326319962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/PACKET POWDER ORAL Rx AB EQ 4GM RESIN/SCOOPFUL POWDER ORAL Rx AB - APOTHECONANDA 07340319942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM RESIN TABLET ORAL Discontinued — EQ 800MG RESIN TABLET ORAL Discontinued — - PARKE DAVISANDA 0716211988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/BAR BAR, CHEWABLE ORAL Discontinued — - PARKE DAVISANDA 0717391988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4GM RESIN/BAR BAR, CHEWABLE ORAL Discontinued —
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
38 yr 10 mo ago
Most recent approval
6 mo ago
Approvals span 1988–2026 across 28 FDA applications.
Brand (NDA) 27%
Generic (ANDA) 2693%
Cholestyramine: 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.
