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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040905

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NDA 040905 describes KALEXATE, which is a drug marketed by Kvk Tech and is included in one NDA. It is available from four suppliers. Additional details are available on the KALEXATE profile page.

The generic ingredient in KALEXATE is sodium polystyrene sulfonate. There are one thousand four hundred and twenty-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 040905
Tradename:KALEXATE
Applicant:Kvk Tech
Ingredient:sodium polystyrene sulfonate
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040905
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KALEXATE sodium polystyrene sulfonate POWDER;ORAL, RECTAL 040905 ANDA Major Pharmaceuticals 0904-6041 N 0904-6041-27
KALEXATE sodium polystyrene sulfonate POWDER;ORAL, RECTAL 040905 ANDA KVK-Tech, Inc. 10702-036 N 10702-036-45

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORAL, RECTALStrength454GM/BOT
Approval Date:Mar 30, 2009TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORAL, RECTALStrength15GM/BOT
Approval Date:Apr 3, 2015TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Chinese Patent Office
QuintilesIMS
Baxter
UBS
US Army
Healthtrust
Harvard Business School
US Department of Justice

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