Details for New Drug Application (NDA): 211276
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NDA 211276 describes DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, which is a drug marketed by Fresenius Kabi Usa, Abbott, B Braun, Icu Medical Inc, and Miles, and is included in six NDAs. It is available from one supplier. Additional details are available on the DEXTROSE 5% AND SODIUM CHLORIDE 0.45% profile page.
The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.45% is dextrose; sodium chloride. There are nine drug master file entries for this compound. Four 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 0.45% is dextrose; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.
Summary for 211276
| Tradename: | DEXTROSE 5% AND SODIUM CHLORIDE 0.45% |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | dextrose; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 211276
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 211276
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | dextrose; sodium chloride | INJECTABLE;INJECTION | 211276 | ANDA | Fresenius Kabi USA, LLC | 63323-869 | 63323-869-10 | 10 BAG in 1 CASE (63323-869-10) / 1000 mL in 1 BAG (63323-869-01) |
| DEXTROSE 5% AND SODIUM CHLORIDE 0.45% | dextrose; sodium chloride | INJECTABLE;INJECTION | 211276 | ANDA | Fresenius Kabi USA, LLC | 63323-869 | 63323-869-74 | 20 BAG in 1 CASE (63323-869-74) / 500 mL in 1 BAG (63323-869-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;450MG/100ML | ||||
| Approval Date: | Sep 15, 2020 | TE: | AP | RLD: | No | ||||
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