Orange Book product

HYDROCORTISONE 1%

Orange Book ANDA 080693 · FOUGERA PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name HYDROCORTISONE
Active ingredients HYDROCORTISONE
Strength 1%
Dosage form CREAM
Route TOPICAL
Application ANDA080693
Applicant holder FOUGERA PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jan 1, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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