Orange Book product

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE

Orange Book ANDA 077847 · HIKMA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Active ingredients DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
Strength EQ 2% BASE;EQ 0.5% BASE
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA077847
Applicant holder HIKMA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 28, 2008

At a glance

  • 10–99 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)

Browse all Orange Book products