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Generated: November 13, 2018

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Details for New Drug Application (NDA): 040028

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NDA 040028 describes KIONEX, which is a drug marketed by Paddock Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the KIONEX profile page.

The generic ingredient in KIONEX is sodium polystyrene sulfonate. There are one thousand four hundred and fifty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.
Summary for 040028
Tradename:KIONEX
Applicant:Paddock Llc
Ingredient:sodium polystyrene sulfonate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040028
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KIONEX sodium polystyrene sulfonate SUSPENSION;ORAL, RECTAL 040028 ANDA Paddock Laboratories, LLC 0574-2002 0574-2002-02 60 mL in 1 BOTTLE (0574-2002-02)
KIONEX sodium polystyrene sulfonate SUSPENSION;ORAL, RECTAL 040028 ANDA Paddock Laboratories, LLC 0574-2002 0574-2002-16 473 mL in 1 BOTTLE (0574-2002-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORAL, RECTALStrength15GM/60ML
Approval Date:Sep 17, 2007TE:AARLD:No

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