Orange Book product

ZADITOR EQ 0.025% BASE

Orange Book ANDA 077200 · ALCON PHARMACEUTICALS LTD · Over the counter

Key facts

Proprietary name ZADITOR
Active ingredients KETOTIFEN FUMARATE
Strength EQ 0.025% BASE
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA077200
Applicant holder ALCON PHARMACEUTICALS LTD
Marketing status Over the counter
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Sep 2, 2008

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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