Orange Book product

PREDNISONE 20MG

Orange Book ANDA 085161 · WATSON LABORATORIES INC · Prescription

Key facts

Proprietary name PREDNISONE
Active ingredients PREDNISONE
Strength 20MG
Dosage form TABLET
Route ORAL
Application ANDA085161
Applicant holder WATSON LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 1, 1982

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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