Details for New Drug Application (NDA): 018897
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NDA 018897 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-five 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-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 018897
| Tradename: | SODIUM CHLORIDE 23.4% |
| Applicant: | Hospira |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 018897
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 018897
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 14.6% | sodium chloride | SOLUTION;INTRAVENOUS | 018897 | NDA | Hospira, Inc. | 0409-1141 | 0409-1141-02 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0409-1141-02) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-1141-12) |
| SODIUM CHLORIDE 23.4% | sodium chloride | SOLUTION;INTRAVENOUS | 018897 | NDA | Hospira, Inc. | 0409-1141 | 0409-1141-02 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0409-1141-02) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0409-1141-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 20, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MEQ/40ML (2.5MEQ/ML) | ||||
| Approval Date: | Jul 20, 1984 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 400MEQ/100ML (4MEQ/ML) | ||||
| Approval Date: | Jun 18, 2020 | TE: | AP | RLD: | Yes | ||||
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