Details for New Drug Application (NDA): 040905
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The generic ingredient in KALEXATE is sodium polystyrene sulfonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twelve 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 |
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: | RX | Dosage: | POWDER;ORAL, RECTAL | Strength | 454GM/BOT | ||||
Approval Date: | Mar 30, 2009 | TE: | AA | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL, RECTAL | Strength | 15GM/BOT | ||||
Approval Date: | Apr 3, 2015 | TE: | RLD: | No |
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