Drug application

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER (DEXTROSE, MAGNESIUM ACETATE, POTASSIUM ACETATE and 1 more)

Drugs@FDA NDA 017610 · OTSUKA ICU MEDCL

Key facts

Drug name NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Active ingredients DEXTROSE, MAGNESIUM ACETATE, POTASSIUM ACETATE, SODIUM CHLORIDE
Application type NDA
Application number 017610
Company OTSUKA ICU MEDCL
Dosage forms INJECTABLE, INJECTION
Strength 5GM/100ML;21MG/100ML;128MG/100ML;234MG/100ML
Marketing status Prescription
Reference listed drug No
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Aug 13, 1975

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • None 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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