FDA Orange Book · active-ingredient family
Colestipol hydrochloride
Colestipol hydrochloride is approved as 2 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COLESTID · NDA 017563
2
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · granule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COLESTIDRLD×4 | PFIZER | NDA 017563 | — | Sep 22, 1995 | |
| COLESTIDRLD | PFIZER | NDA 020222 | AB | Jul 19, 1994 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COLESTIPOL HYDROCHLORIDE | PHARMOBEDIENT | ANDA 220012 | AB | Sep 15, 2025 | |
| COLESTIPOL HYDROCHLORIDE | RICONPHARMA LLC | ANDA 217462 | AB | Dec 03, 2024 | |
| COLESTIPOL HYDROCHLORIDE | EDENBRIDGE PHARMS | ANDA 217667 | AB | Aug 16, 2024 | |
| COLESTIPOL HYDROCHLORIDE | ANI PHARMS | ANDA 216517 | AB | Mar 10, 2023 | |
| COLESTIPOL HYDROCHLORIDE | ZYDUS PHARMS | ANDA 215223 | AB | Mar 10, 2022 | |
| COLESTIPOL HYDROCHLORIDE | IMPAX LABS | ANDA 077510 | AB | Oct 24, 2006 | |
| COLESTIPOL HYDROCHLORIDE×2 | IMPAX LABS | ANDA 077277 | — | May 02, 2006 |
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.
Colestipol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
