Orange Book product

HYDROCORTISONE 2.5%

Orange Book ANDA 040503 · CHARTWELL MOLECULAR HOLDINGS LLC · Discontinued

Key facts

Proprietary name HYDROCORTISONE
Active ingredients HYDROCORTISONE
Strength 2.5%
Dosage form CREAM
Route TOPICAL
Application ANDA040503
Applicant holder CHARTWELL MOLECULAR HOLDINGS LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 12, 2004

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)

Browse all Orange Book products