Orange Book product · Generic (ANDA)
COLESEVELAM HYDROCHLORIDE
COLESEVELAM HYDROCHLORIDE
At a glance
Oct 14, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 14, 2021
4 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
COLESEVELAM HYDROCHLORIDE
Strength
625MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 206036
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of COLESEVELAM HYDROCHLORIDE
- 2019WELCHOLBrand (NDA)
NDA 210895 · COSETTE
- 2009WELCHOLBrand (NDA)
NDA 022362 · COSETTE
- 2000WELCHOLBrand (NDA)
NDA 021141 · COSETTE
- 2000WELCHOLBrand (NDA)
NDA 021176 · COSETTE
- 2025COLESEVELAM HYDROCHLORIDEGeneric (ANDA)
ANDA 204893 · MACLEODS PHARMS LTD
- 2023COLESEVELAM HYDROCHLORIDEGeneric (ANDA)
ANDA 212886 · IMPAX
- 2022COLESEVELAM HYDROCHLORIDEGeneric (ANDA)
ANDA 213456 · UNITED RES LABS
- 2020COLESEVELAM HYDROCHLORIDEGeneric (ANDA)
ANDA 201354 · CHARTWELL RX
- 2020COLESEVELAM HYDROCHLORIDEGeneric (ANDA)
ANDA 212050 · INVENTIA
- 2020COLESEVELAM HYDROCHLORIDEGeneric (ANDA)
ANDA 200830 · WATSON LABS INC
- 2020COLESEVELAM HYDROCHLORIDEGeneric (ANDA)
ANDA 202178 · WATSON LABS INC
- 2020COLESEVELAM HYDROCHLORIDEGeneric (ANDA)
ANDA 209946 · ZHEJIANG JINGXIN
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.
