Orange Book product

ALCLOMETASONE DIPROPIONATE 0.05%

Orange Book ANDA 076884 · FOUGERA PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name ALCLOMETASONE DIPROPIONATE
Active ingredients ALCLOMETASONE DIPROPIONATE
Strength 0.05%
Dosage form OINTMENT
Route TOPICAL
Application ANDA076884
Applicant holder FOUGERA PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Jul 18, 2005

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)

Browse all Orange Book products