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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204071


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NDA 204071 describes SODIUM POLYSTYRENE SULFONATE, which is a drug marketed by Belcher, Chartwell Rx, Citrusphrma, Cmp Pharma Inc, Epic Pharma Llc, Nuvo Pharms Inc, Pai Holdings Pharm, Upsher Smith Labs, Ani Pharms, Hikma, Morton Grove, and Roxane, and is included in twelve NDAs. It is available from nine suppliers. Additional details are available on the SODIUM POLYSTYRENE SULFONATE profile page.

The generic ingredient in SODIUM POLYSTYRENE SULFONATE is sodium polystyrene sulfonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.
Summary for 204071
Tradename:SODIUM POLYSTYRENE SULFONATE
Applicant:Nuvo Pharms Inc
Ingredient:sodium polystyrene sulfonate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate POWDER;ORAL, RECTAL 204071 ANDA Marlex Pharmaceuticals Inc 10135-146 10135-146-14 15 g in 1 BOTTLE, PLASTIC (10135-146-14)
SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate POWDER;ORAL, RECTAL 204071 ANDA Marlex Pharmaceuticals Inc 10135-146 10135-146-17 454 g in 1 JAR (10135-146-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORAL, RECTALStrength454GM/BOT
Approval Date:Nov 28, 2014TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORAL, RECTALStrength15GM/BOT
Approval Date:Nov 28, 2014TE:RLD:No

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