Last Updated: September 24, 2026

Details for New Drug Application (NDA): 214912


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NDA 214912 describes SODIUM POLYSTYRENE SULFONATE, which is a drug marketed by Ajenat Pharms, Chartwell Rx, Citrusphrma, Cmp Pharma Inc, Epic Pharma Llc, Nuvo Pharms Inc, Pai Holdings Pharm, Upsher Smith Labs, Ani Pharms, Hikma, Lyne, Morton Grove, and Roxane, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the SODIUM POLYSTYRENE SULFONATE profile page.

The generic ingredient in SODIUM POLYSTYRENE SULFONATE is sodium polystyrene sulfonate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.
Summary for 214912
Tradename:SODIUM POLYSTYRENE SULFONATE
Applicant:Lyne
Ingredient:sodium polystyrene sulfonate
Patents:0
Suppliers and Packaging for NDA: 214912
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate SUSPENSION;ORAL, RECTAL 214912 ANDA Burel Pharmaceuticals, LLC 35573-108 35573-108-14 10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13)
SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate SUSPENSION;ORAL, RECTAL 214912 ANDA Burel Pharmaceuticals, LLC 35573-108 35573-108-57 473 mL in 1 BOTTLE (35573-108-57)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORAL, RECTALStrength15GM/60ML
Approval Date:Jun 10, 2025TE:AARLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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