Details for New Drug Application (NDA): 212070
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The generic ingredient in SODIUM CHLORIDE 23.4% is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 212070
Tradename: | SODIUM CHLORIDE 23.4% |
Applicant: | Fresenius Kabi Usa |
Ingredient: | sodium chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212070
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 212070
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 14.6% | sodium chloride | SOLUTION;INTRAVENOUS | 212070 | ANDA | Fresenius Kabi USA, LLC | 63323-090 | 63323-090-20 | 25 VIAL, PLASTIC in 1 TRAY (63323-090-20) / 20 mL in 1 VIAL, PLASTIC (63323-090-02) |
SODIUM CHLORIDE 14.6% | sodium chloride | SOLUTION;INTRAVENOUS | 212070 | ANDA | Fresenius Kabi USA, LLC | 63323-090 | 63323-090-40 | 25 VIAL, PLASTIC in 1 TRAY (63323-090-40) / 40 mL in 1 VIAL, PLASTIC (63323-090-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MEQ/20ML (2.5MEQ/ML) | ||||
Approval Date: | Apr 28, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MEQ/40ML (2.5MEQ/ML) | ||||
Approval Date: | Apr 28, 2021 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 400MEQ/100ML (4MEQ/ML) | ||||
Approval Date: | Feb 14, 2022 | TE: | AP | RLD: | No |
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