Orange Book product

PREDNISOLONE 5MG/5ML

Orange Book ANDA 040423 · NESHER PHARMACEUTICALS USA LLC · Discontinued

Key facts

Proprietary name PREDNISOLONE
Active ingredients PREDNISOLONE
Strength 5MG/5ML
Dosage form SYRUP
Route ORAL
Application ANDA040423
Applicant holder NESHER PHARMACEUTICALS USA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 22, 2001

At a glance

  • None 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)

Browse all Orange Book products