Details for New Drug Application (NDA): 212347
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NDA 212347 describes POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%, which is a drug marketed by Baxter Hlthcare, Fresenius Kabi Usa, and B Braun, and is included in three NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% profile page.
The generic ingredient in POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
The generic ingredient in POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Summary for 212347
| Tradename: | POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | potassium chloride; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 212347
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 212347
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 212347 | ANDA | Fresenius Kabi USA, LLC | 63323-683 | 63323-683-10 | 10 BAG in 1 CARTON (63323-683-10) / 1000 mL in 1 BAG (63323-683-01) |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 212347 | ANDA | Fresenius Kabi USA, LLC | 63323-686 | 63323-686-10 | 10 BAG in 1 CARTON (63323-686-10) / 1000 mL in 1 BAG (63323-686-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 150MG/100ML;450MG/100ML | ||||
| Approval Date: | Sep 17, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300MG/100ML;900MG/100ML | ||||
| Approval Date: | Sep 17, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 150MG/100ML;900MG/100ML | ||||
| Approval Date: | Jun 2, 2021 | TE: | AP | RLD: | No | ||||
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