Orange Book product

FLUTICASONE PROPIONATE 0.005%

Orange Book ANDA 076668 · PADAGIS ISRAEL PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name FLUTICASONE PROPIONATE
Active ingredients FLUTICASONE PROPIONATE
Strength 0.005%
Dosage form OINTMENT
Route TOPICAL
Application ANDA076668
Applicant holder PADAGIS ISRAEL PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 14, 2004

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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