Details for New Drug Application (NDA): 017799
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NDA 017799 describes DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, which is a drug marketed by Abbott, Fresenius Kabi Usa, Miles, Otsuka Icu Medcl, and B Braun, and is included in six NDAs. It is available from two suppliers. Additional details are available on the DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER is dextrose; sodium chloride. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.
The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER is dextrose; sodium chloride. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.
Summary for 017799
| Tradename: | DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER |
| Applicant: | Otsuka Icu Medcl |
| Ingredient: | dextrose; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 017799
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 017799
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | dextrose; sodium chloride | INJECTABLE;INJECTION | 017799 | NDA | ICU Medical Inc. | 0990-7925 | 0990-7925-03 | 24 POUCH in 1 CASE (0990-7925-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | dextrose; sodium chloride | INJECTABLE;INJECTION | 017799 | NDA | ICU Medical Inc. | 0990-7925 | 0990-7925-09 | 12 POUCH in 1 CASE (0990-7925-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;300MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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