Orange Book product

PREDNISOLONE 15MG/5ML

Orange Book ANDA 040399 · PHARMACEUTICAL ASSOCIATES INC · Discontinued

Key facts

Proprietary name PREDNISOLONE
Active ingredients PREDNISOLONE
Strength 15MG/5ML
Dosage form SOLUTION
Route ORAL
Application ANDA040399
Applicant holder PHARMACEUTICAL ASSOCIATES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 5, 2003

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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