Orange Book product

ALA-CORT 2.5%

Orange Book ANDA 080706 · CROWN LABORATORIES INC · Prescription

Key facts

Proprietary name ALA-CORT
Active ingredients HYDROCORTISONE
Strength 2.5%
Dosage form CREAM
Route TOPICAL
Application ANDA080706
Applicant holder CROWN LABORATORIES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 5, 2016

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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