Orange Book product · Brand (NDA)
RENVELA
SEVELAMER CARBONATE
At a glance
Oct 19, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 19, 2007
18 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
SEVELAMER CARBONATE
Strength
800MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022127
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2009RENVELABrand (NDA)
NDA 022318 · GENZYME
- 2025SEVELAMER CARBONATEGeneric (ANDA)
ANDA 219931 · NAVINTA LLC
- 2025SEVELAMER CARBONATEGeneric (ANDA)
ANDA 215909 · TORRENT
- 2024SEVELAMER CARBONATEGeneric (ANDA)
ANDA 215998 · SHANDONG XINHUA
- 2024SEVELAMER CARBONATEGeneric (ANDA)
ANDA 206234 · INVAGEN PHARMS
- 2024SEVELAMER CARBONATEGeneric (ANDA)
ANDA 211915 · STRIDES PHARMA
- 2024SEVELAMER CARBONATEGeneric (ANDA)
ANDA 207291 · MACLEODS PHARMS LTD
- 2023SEVELAMER CARBONATEGeneric (ANDA)
ANDA 211917 · STRIDES PHARMA INTL
- 2023SEVELAMER CARBONATEGeneric (ANDA)
ANDA 206100 · MACLEODS PHARMS LTD
- 2023SEVELAMER CARBONATEGeneric (ANDA)
ANDA 217319 · CHARTWELL RX
- 2022SEVELAMER CARBONATEGeneric (ANDA)
ANDA 215537 · MICRO LABS
- 2021SEVELAMER CARBONATEGeneric (ANDA)
ANDA 201513 · LUPIN
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.
