Orange Book product

SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT

Orange Book ANDA 088786 · PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC · Discontinued

Key facts

Proprietary name SODIUM POLYSTYRENE SULFONATE
Active ingredients SODIUM POLYSTYRENE SULFONATE
Strength 453.6GM/BOT
Dosage form POWDER
Route ORAL, RECTAL
Application ANDA088786
Applicant holder PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Sep 11, 1984

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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