Orange Book product

XALATAN 0.005%

Orange Book NDA 020597 · UPJOHN US 2 LLC · Prescription

Key facts

Proprietary name XALATAN
Active ingredients LATANOPROST
Strength 0.005%
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application NDA020597
Applicant holder UPJOHN US 2 LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jun 5, 1996

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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