Details for New Drug Application (NDA): 210332
✉ Email this page to a colleague
NDA 210332 describes DEXTROSE 5% AND LACTATED RINGER'S, which is a drug marketed by Fresenius Kabi Usa and Otsuka Icu Medcl and is included in two NDAs. It is available from one supplier. Additional details are available on the DEXTROSE 5% AND LACTATED RINGER'S profile page.
The generic ingredient in DEXTROSE 5% AND LACTATED RINGER'S is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.
The generic ingredient in DEXTROSE 5% AND LACTATED RINGER'S is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.
Summary for 210332
| Tradename: | DEXTROSE 5% AND LACTATED RINGER'S |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate |
| Patents: | 0 |
Pharmacology for NDA: 210332
| Mechanism of Action | Osmotic Activity Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 210332
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND LACTATED RINGER'S | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | INJECTABLE;INJECTION | 210332 | ANDA | Fresenius Kabi USA, LLC | 65219-241 | 65219-241-10 | 10 BAG in 1 CASE (65219-241-10) / 1000 mL in 1 BAG (65219-241-00) |
| DEXTROSE 5% AND LACTATED RINGER'S | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | INJECTABLE;INJECTION | 210332 | ANDA | Fresenius Kabi USA, LLC | 65219-243 | 65219-243-50 | 20 BAG in 1 CASE (65219-243-50) / 500 mL in 1 BAG (65219-243-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | ||||
| Approval Date: | Mar 28, 2022 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
