Orange Book product

MICORT-HC 2.5%

Orange Book ANDA 040396 · LEGACY PHARMA INC SEZC · Prescription

Key facts

Proprietary name MICORT-HC
Active ingredients HYDROCORTISONE ACETATE
Strength 2.5%
Dosage form CREAM
Route TOPICAL
Application ANDA040396
Applicant holder LEGACY PHARMA INC SEZC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 27, 2001

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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