Details for New Drug Application (NDA): 211190
NDA 211190 describes DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, and Hospira, and is included in five NDAs. It is available from three suppliers. Additional details are available on the DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is dextrose; sodium chloride. There is one drug master file entry 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 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is dextrose; sodium chloride. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.
Summary for 211190
| Tradename: | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | dextrose; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 211190
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 211190
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | dextrose; sodium chloride | INJECTABLE;INJECTION | 211190 | ANDA | Fresenius Kabi USA, LLC | 63323-874 | 63323-874-10 | 10 BAG in 1 CASE (63323-874-10) / 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2.5GM/100ML;450MG/100ML | ||||
| Approval Date: | Dec 20, 2019 | TE: | AP | RLD: | No | ||||
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