Orange Book product

BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

Orange Book ANDA 075503 · EPIC PHARMA LLC · Discontinued

Key facts

Proprietary name BALANCED SALT
Active ingredients CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE
Strength 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML
Dosage form SOLUTION
Route IRRIGATION
Application ANDA075503
Applicant holder EPIC PHARMA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 27, 2006

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No 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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