Orange Book product

SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT

Orange Book ANDA 202333 · EPIC PHARMA LLC · Prescription

Key facts

Proprietary name SODIUM POLYSTYRENE SULFONATE
Active ingredients SODIUM POLYSTYRENE SULFONATE
Strength 453.6GM/BOT
Dosage form POWDER
Route ORAL, RECTAL
Application ANDA202333
Applicant holder EPIC PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 19, 2014

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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