Orange Book product

BSS 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

Orange Book NDA 020742 · ALCON LABORATORIES INC · Prescription

Key facts

Proprietary name BSS
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 NDA020742
Applicant holder ALCON LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Dec 10, 1997

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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