Orange Book product

FLUOCINONIDE EMULSIFIED BASE 0.05%

Orange Book ANDA 076586 · FOUGERA PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name FLUOCINONIDE EMULSIFIED BASE
Active ingredients FLUOCINONIDE
Strength 0.05%
Dosage form CREAM
Route TOPICAL
Application ANDA076586
Applicant holder FOUGERA PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB2
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 23, 2004

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)

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