Orange Book product

KIONEX 454GM/BOT

Orange Book ANDA 040029 · ANI PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name KIONEX
Active ingredients SODIUM POLYSTYRENE SULFONATE
Strength 454GM/BOT
Dosage form POWDER
Route ORAL, RECTAL
Application ANDA040029
Applicant holder ANI PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 6, 1998

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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