Details for New Drug Application (NDA): 217796
✉ Email this page to a colleague
NDA 217796 describes SODIUM CHLORIDE 23.4%, which is a drug marketed by Fresenius Kabi Usa, Hospira, and Abraxis Pharm, and is included in five NDAs. It is available from three suppliers. Additional details are available on the SODIUM CHLORIDE 23.4% profile page.
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-seven suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
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-seven 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 |
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 | ||||
Complete Access Available with Subscription
