Orange Book product

POTASSIUM CHLORIDE 10MEQ

Orange Book ANDA 211797 · GRANULES PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name POTASSIUM CHLORIDE
Active ingredients POTASSIUM CHLORIDE
Strength 10MEQ
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Application ANDA211797
Applicant holder GRANULES PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB2
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 4, 2020

At a glance

  • 10–99 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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