Details for New Drug Application (NDA): 018893
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NDA 018893 describes SODIUM ACETATE, which is a drug marketed by Amneal, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Milla Pharms, and Somerset Theraps Llc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the SODIUM ACETATE profile page.
The generic ingredient in SODIUM ACETATE is sodium acetate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
The generic ingredient in SODIUM ACETATE is sodium acetate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
Summary for 018893
| Tradename: | SODIUM ACETATE |
| Applicant: | Hospira |
| Ingredient: | sodium acetate |
| Patents: | 0 |
Pharmacology for NDA: 018893
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 018893
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | sodium acetate | SOLUTION;INTRAVENOUS | 018893 | NDA | Hospira, Inc. | 0409-3299 | 0409-3299-05 | 25 VIAL in 1 TRAY (0409-3299-05) / 50 mL in 1 VIAL (0409-3299-15) |
| SODIUM ACETATE | sodium acetate | SOLUTION;INTRAVENOUS | 018893 | NDA | Hospira, Inc. | 0409-3299 | 0409-3299-06 | 25 VIAL in 1 CASE (0409-3299-06) / 100 mL in 1 VIAL (0409-3299-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 40MEQ/20ML (2MEQ/ML) | ||||
| Approval Date: | May 4, 1983 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MEQ/50ML (2MEQ/ML) | ||||
| Approval Date: | Sep 2, 2014 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MEQ/100ML (2MEQ/ML) | ||||
| Approval Date: | Sep 2, 2014 | TE: | AP | RLD: | Yes | ||||
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