Orange Book product

PERMETHRIN 5%

Orange Book ANDA 076369 · PADAGIS ISRAEL PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name PERMETHRIN
Active ingredients PERMETHRIN
Strength 5%
Dosage form CREAM
Route TOPICAL
Application ANDA076369
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 Apr 21, 2003

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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