Orange Book product

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 18MG/2ML (9MG/ML)

Orange Book ANDA 088912 · FRESENIUS KABI USA LLC · Prescription

Key facts

Proprietary name SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Active ingredients SODIUM CHLORIDE
Strength 18MG/2ML (9MG/ML)
Dosage form SOLUTION
Route INJECTION
Application ANDA088912
Applicant holder FRESENIUS KABI USA LLC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Nov 29, 1985

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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