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 one supplier. Additional details are available on the KALEXATE profile page.
The generic ingredient in KALEXATE is sodium polystyrene sulfonate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.
The generic ingredient in KALEXATE is sodium polystyrene sulfonate. There is one drug master file entry for this compound. Eleven 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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