Orange Book product

DICLOFENAC POTASSIUM 50MG

Orange Book ANDA 075229 · RUBICON RESEARCH LTD · Prescription

Key facts

Proprietary name DICLOFENAC POTASSIUM
Active ingredients DICLOFENAC POTASSIUM
Strength 50MG
Dosage form TABLET
Route ORAL
Application ANDA075229
Applicant holder RUBICON RESEARCH LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Nov 20, 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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