Details for New Drug Application (NDA): 217796
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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 217796
Tradename: | SODIUM CHLORIDE 23.4% |
Applicant: | Fresenius Kabi Usa |
Ingredient: | sodium chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217796
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 217796
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 23.4% | sodium chloride | INJECTABLE;INJECTION | 217796 | ANDA | Fresenius Kabi USA, LLC | 63323-099 | 63323-099-63 | 10 VIAL, PLASTIC in 1 TRAY (63323-099-63) / 200 mL in 1 VIAL, PLASTIC (63323-099-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 234MG/ML | ||||
Approval Date: | Jul 11, 2023 | TE: | AP | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Jan 23, 2024 | ||||||||
Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY |
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