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Details for New Drug Application (NDA): 089049

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NDA 089049 describes SODIUM POLYSTYRENE SULFONATE, which is a drug marketed by Citrusphrma, Carolina Medcl, Cedar Pharms, Invatech Pharma, Morton Grove, Belcher Pharms Llc, Epic Pharma Llc, Roxane, Nuvo Pharm Inc, Wockhardt, and Paddock Llc, and is included in twelve 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 are one thousand three hundred and fifty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.

Summary for NDA: 089049

Tradename:
SODIUM POLYSTYRENE SULFONATE
Applicant:
Roxane
Ingredient:
sodium polystyrene sulfonate
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 089049

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM POLYSTYRENE SULFONATE
sodium polystyrene sulfonate
SUSPENSION;ORAL, RECTAL 089049 ANDA West-Ward Pharmaceuticals Corp. 0054-0379 0054-0379-50 1 BOTTLE in 1 CARTON (0054-0379-50) > 120 mL in 1 BOTTLE
SODIUM POLYSTYRENE SULFONATE
sodium polystyrene sulfonate
SUSPENSION;ORAL, RECTAL 089049 ANDA West-Ward Pharmaceuticals Corp. 0054-0379 0054-0379-51 60 mL in 1 BOTTLE, UNIT-DOSE (0054-0379-51)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORAL, RECTALStrength15GM/60ML
Approval Date:Nov 17, 1986TE:AARLD:No


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