Orange Book product · Brand (NDA)
RENAGEL
SEVELAMER HYDROCHLORIDE
At a glance
Oct 30, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 30, 1998
28 yr ago
Today
Pharmaceutical detail
Active ingredient
SEVELAMER HYDROCHLORIDE
Strength
403MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 020926
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2000RENAGELBrand (NDA)
NDA 021179 · GENZYME
- 2025SEVELAMER HYDROCHLORIDEGeneric (ANDA)
ANDA 218966 · NAVINTA LLC
- 2023SEVELAMER HYDROCHLORIDEGeneric (ANDA)
ANDA 212599 · AUROBINDO PHARMA LTD
- 2023SEVELAMER HYDROCHLORIDEGeneric (ANDA)
ANDA 206883 · MACLEODS PHARMS LTD
- 2021SEVELAMER HYDROCHLORIDEGeneric (ANDA)
ANDA 213145 · LUPIN
- 2020SEVELAMER HYDROCHLORIDEGeneric (ANDA)
ANDA 201068 · RISING
- 2019SEVELAMER HYDROCHLORIDEGeneric (ANDA)
ANDA 204724 · GLENMARK PHARMS LTD
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.
