Orange Book product

FLUOCINONIDE 0.05%

Orange Book ANDA 073085 · COSETTE PHARMACEUTICALS NC LABORATORIES LLC · Prescription

Key facts

Proprietary name FLUOCINONIDE
Active ingredients FLUOCINONIDE
Strength 0.05%
Dosage form CREAM
Route TOPICAL
Application ANDA073085
Applicant holder COSETTE PHARMACEUTICALS NC LABORATORIES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB1
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 14, 1992

At a glance

  • 10–99 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