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Generated: November 15, 2018

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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 three 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 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 040905
Tradename:KALEXATE
Applicant:Kvk Tech
Ingredient:sodium polystyrene sulfonate
Patents:0
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 KVK-Tech, Inc. 10702-036 10702-036-15 15 g in 1 BOTTLE (10702-036-15)
KALEXATE sodium polystyrene sulfonate POWDER;ORAL, RECTAL 040905 ANDA KVK-Tech, Inc. 10702-036 10702-036-45 454 g in 1 JAR (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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