Orange Book product

ELIMITE 5%

Orange Book NDA 019855 · AUROBINDO PHARMA USA INC · Prescription

Key facts

Proprietary name ELIMITE
Active ingredients PERMETHRIN
Strength 5%
Dosage form CREAM
Route TOPICAL
Application NDA019855
Applicant holder AUROBINDO PHARMA USA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Aug 25, 1989

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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