Drug application

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER (MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC and 4 more)

Drugs@FDA NDA 019696 · B BRAUN

Key facts

Drug name ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
Active ingredients MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Application type NDA
Application number 019696
Company B BRAUN
Dosage forms INJECTABLE, INJECTION
Strength 30MG/100ML;37MG/100ML;0.82MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML;12MG/100ML
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date Sep 29, 1989

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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