Orange Book product · Brand (NDA)
RENAGEL
SEVELAMER HYDROCHLORIDE
At a glance
Jul 12, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 12, 2000
26 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
SEVELAMER HYDROCHLORIDE
Strength
400MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021179
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1998RENAGELBrand (NDA)
NDA 020926 · 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.
