Orange Book product

SPS 15GM/60ML

Orange Book ANDA 087859 · CMP PHARMA INC · Prescription

Key facts

Proprietary name SPS
Active ingredients SODIUM POLYSTYRENE SULFONATE
Strength 15GM/60ML
Dosage form SUSPENSION
Route ORAL, RECTAL
Application ANDA087859
Applicant holder CMP PHARMA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Dec 8, 1982

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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