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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 three hundred and thirty-six 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: 040028

Paddock Llc
sodium polystyrene sulfonate
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents

Suppliers and Packaging for NDA: 040028

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sodium polystyrene sulfonate
SUSPENSION;ORAL, RECTAL 040028 ANDA Paddock Laboratories, LLC 0574-2002 0574-2002-02 60 mL in 1 BOTTLE (0574-2002-02)
sodium polystyrene sulfonate
SUSPENSION;ORAL, RECTAL 040028 ANDA Paddock Laboratories, LLC 0574-2002 0574-2002-16 473 mL in 1 BOTTLE (0574-2002-16)

Summary for product number 001

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

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