FDA Orange Book · active-ingredient family
Cholestyramine
Cholestyramine is approved as 2 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:QUESTRAN LIGHT · NDA 019669
2
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · bar, chewable, powder, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QUESTRAN LIGHTRLD×2 | BRISTOL MYERS | NDA 019669 | — | Dec 05, 1988 | |
| QUESTRANRLD×2 | BRISTOL MYERS | NDA 016640 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHOLESTYRAMINE | MICRO LABS | ANDA 219318 | AB | Mar 05, 2026 | |
| CHOLESTYRAMINE×2 | MACLEODS PHARMS LTD | ANDA 207294 | AB | Nov 21, 2024 | |
| CHOLESTYRAMINE LIGHT×2 | MACLEODS PHARMS LTD | ANDA 209109 | — | Oct 31, 2024 | |
| CHOLESTYRAMINE×2 | AIPING PHARM INC | ANDA 214877 | — | Jan 21, 2022 | |
| CHOLESTYRAMINE×2 | ALKEM LABS LTD | ANDA 211856 | AB | Oct 19, 2021 | |
| CHOLESTYRAMINE LIGHT×2 | ALKEM LABS LTD | ANDA 211799 | AB | Oct 19, 2021 | |
| CHOLESTYRAMINE×2 | PHARMOBEDIENT | ANDA 209597 | AB | Mar 09, 2021 | |
| CHOLESTYRAMINE LIGHT×2 | PHARMOBEDIENT CNSLTG | ANDA 209599 | AB | Nov 12, 2020 | |
| CHOLESTYRAMINE×2 | AJANTA PHARMA LTD | ANDA 211119 | AB | Apr 06, 2020 | |
| CHOLESTYRAMINE | ZYDUS PHARMS | ANDA 202901 | AB | Jul 02, 2018 | |
| CHOLESTYRAMINE LIGHT×2 | ZYDUS PHARMS | ANDA 202902 | AB | Apr 25, 2017 | |
| CHOLESTYRAMINE×2 | PH HEALTH | ANDA 077204 | AB | Aug 26, 2005 | |
| CHOLESTYRAMINE LIGHT×2 | PH HEALTH | ANDA 077203 | AB | Aug 26, 2005 | |
| CHOLESTYRAMINE LIGHT×2 | TEVA PHARMS | ANDA 074555 | — | Sep 30, 1998 | |
| CHOLESTYRAMINE×2 | TEVA | ANDA 074347 | — | May 28, 1998 | |
| CHOLESTYRAMINE LIGHT×2 | TEVA | ANDA 074348 | — | May 28, 1998 | |
| CHOLESTYRAMINE×2 | IVAX SUB TEVA PHARMS | ANDA 074771 | — | Jul 09, 1997 | |
| CHOLESTYRAMINE×2 | ANI PHARMS | ANDA 074554 | — | Oct 02, 1996 | |
| CHOLESTYRAMINE×2 | EPIC PHARMA LLC | ANDA 074557 | AB | Aug 15, 1996 | |
| CHOLESTYRAMINE LIGHT×2 | EPIC PHARMA LLC | ANDA 074558 | AB | Aug 15, 1996 | |
| LOCHOLEST×2 | CHARTWELL RX | ANDA 074561 | AB | Aug 15, 1996 | |
| LOCHOLEST LIGHT×2 | CHARTWELL RX | ANDA 074562 | AB | Aug 15, 1996 | |
| PREVALITE×2 | AIPING PHARM INC | ANDA 073263 | AB | Feb 22, 1996 | |
| QUESTRAN×2 | APOTHECON | ANDA 073403 | — | Apr 28, 1994 | |
| CHOLYBAR | PARKE DAVIS | ANDA 071621 | — | May 26, 1988 | |
| CHOLYBAR | PARKE DAVIS | ANDA 071739 | — | May 26, 1988 |
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.
Cholestyramine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
