Details for New Drug Application (NDA): 019631
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NDA 019631 describes DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Abbott, B Braun, Miles, and Otsuka Icu Medcl, and is included in five NDAs. It is available from two suppliers. Additional details are available on the DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.9% 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 0.9% 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 019631
| Tradename: | DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | B Braun |
| Ingredient: | dextrose; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 019631
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 019631
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | dextrose; sodium chloride | INJECTABLE;INJECTION | 019631 | NDA | B. Braun Medical Inc. | 0264-7608 | 0264-7608-00 | 12 CONTAINER in 1 CASE (0264-7608-00) / 1000 mL in 1 CONTAINER |
| DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | dextrose; sodium chloride | INJECTABLE;INJECTION | 019631 | NDA | B. Braun Medical Inc. | 0264-7608 | 0264-7608-00 | 12 CONTAINER in 1 CASE (0264-7608-00) / 1000 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/100ML;110MG/100ML | ||||
| Approval Date: | Feb 24, 1988 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/100ML;200MG/100ML | ||||
| Approval Date: | Feb 24, 1988 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/100ML;330MG/100ML | ||||
| Approval Date: | Feb 24, 1988 | TE: | RLD: | No | |||||
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