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DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

NDA · New Drug Application · Sponsor: OTSUKA ICU MEDCL · Approved 1975-08-13

Drug application

FDA Application #
NDA017608
Application type
New Drug Application
Brand name
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
Generic name
SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE
Active ingredients
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
OTSUKA ICU MEDCL
Manufacturer
ICU Medical Inc.
First approval
1975-08-13

Source

Authoritative
Drugs@FDA application overview
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