Orange Book product

PLEGISOL IN PLASTIC CONTAINER 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML

Orange Book NDA 018608 · HOSPIRA INC · Prescription

Key facts

Proprietary name PLEGISOL IN PLASTIC CONTAINER
Active ingredients CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE
Strength 17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML
Dosage form SOLUTION
Route PERFUSION, CARDIAC
Application NDA018608
Applicant holder HOSPIRA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Feb 26, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

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

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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