Orange Book product

CICLOPIROX 0.77%

Orange Book ANDA 078463 · COSETTE PHARMACEUTICALS NC LABORATORIES LLC · Prescription

Key facts

Proprietary name CICLOPIROX
Active ingredients CICLOPIROX
Strength 0.77%
Dosage form CREAM
Route TOPICAL
Application ANDA078463
Applicant holder COSETTE PHARMACEUTICALS NC LABORATORIES LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 20, 2010

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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