Orange Book product

CICLOPIROX 1%

Orange Book ANDA 090490 · ACTAVIS MID ATLANTIC LLC · Prescription

Key facts

Proprietary name CICLOPIROX
Active ingredients CICLOPIROX
Strength 1%
Dosage form SHAMPOO
Route TOPICAL
Application ANDA090490
Applicant holder ACTAVIS MID ATLANTIC LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 24, 2009

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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