Orange Book product · Brand (NDA)
KAYEXALATE
SODIUM POLYSTYRENE SULFONATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
SODIUM POLYSTYRENE SULFONATE
Strength
453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
POWDER
Route
ORAL, RECTAL
TE code
Not listed
Application
NDA 011287
Product number
001
Marketing status
DISCN
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.
- 2025SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 214912 · LYNE
- 2016SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 205727 · AJENAT PHARMS
- 2016SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 206815 · CHARTWELL RX
- 2015KALEXATEGeneric (ANDA)
ANDA 040905 · KVK TECH
- 2014SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 204071 · NUVO PHARMS INC
- 2014SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 202333 · EPIC PHARMA LLC
- 2011SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 090313 · UPSHER SMITH LABS
- 2011SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 090590 · ANI PHARMS
- 2008SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 040909 · CITRUSPHRMA
- 2007KIONEXGeneric (ANDA)
ANDA 040028 · ANI PHARMS
- 1998KIONEXGeneric (ANDA)
ANDA 040029 · ANI PHARMS
- 1989SODIUM POLYSTYRENE SULFONATEGeneric (ANDA)
ANDA 089910 · CMP PHARMA INC
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.
