Orange Book product

LOPROX 0.77%

Orange Book NDA 018748 · EUROFARMA INC · Prescription

Key facts

Proprietary name LOPROX
Active ingredients CICLOPIROX
Strength 0.77%
Dosage form CREAM
Route TOPICAL
Application NDA018748
Applicant holder EUROFARMA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Dec 30, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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