Details for New Drug Application (NDA): 209338
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NDA 209338 describes LACTATED RINGER'S IN PLASTIC CONTAINER, which is a drug marketed by Abbott, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Icu Medical Inc, and Miles, and is included in twelve NDAs. It is available from seven suppliers. Additional details are available on the LACTATED RINGER'S IN PLASTIC CONTAINER profile page.
The generic ingredient in LACTATED RINGER'S IN PLASTIC CONTAINER is calcium chloride; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcium chloride; potassium chloride; sodium chloride; sodium lactate profile page.
The generic ingredient in LACTATED RINGER'S IN PLASTIC CONTAINER is calcium chloride; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcium chloride; potassium chloride; sodium chloride; sodium lactate profile page.
Summary for 209338
| Tradename: | LACTATED RINGER'S IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | calcium chloride; potassium chloride; sodium chloride; sodium lactate |
| Patents: | 0 |
Pharmacology for NDA: 209338
| 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: 209338
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LACTATED RINGER'S IN PLASTIC CONTAINER | calcium chloride; potassium chloride; sodium chloride; sodium lactate | INJECTABLE;INJECTION | 209338 | ANDA | Becton Dickinson and Company | 17271-710 | 17271-710-05 | 30 BAG in 1 CARTON (17271-710-05) / 250 mL in 1 BAG |
| LACTATED RINGER'S IN PLASTIC CONTAINER | calcium chloride; potassium chloride; sodium chloride; sodium lactate | INJECTABLE;INJECTION | 209338 | ANDA | Becton Dickinson and Company | 17271-710 | 17271-710-06 | 20 BAG in 1 CARTON (17271-710-06) / 500 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | ||||
| Approval Date: | Jan 28, 2019 | TE: | AP | RLD: | No | ||||
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