Drug application

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE, DEXTROSE, POTASSIUM CHLORIDE and 2 more)

Drugs@FDA NDA 017608 · OTSUKA ICU MEDCL

Key facts

Drug name DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
Active ingredients CALCIUM CHLORIDE, DEXTROSE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE
Application type NDA
Application number 017608
Company OTSUKA ICU MEDCL
Dosage forms INJECTABLE, INJECTION
Strength 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML
Marketing status Prescription
TE codes AP
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Aug 13, 1975

At a glance

  • 1–9 Submissions
  • 100–999 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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