Orange Book product

TIMOLOL MALEATE EQ 0.5% BASE

Orange Book ANDA 078771 · MANKIND PHARMA LTD · Prescription

Key facts

Proprietary name TIMOLOL MALEATE
Active ingredients TIMOLOL MALEATE
Strength EQ 0.5% BASE
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA078771
Applicant holder MANKIND PHARMA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AT1
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 28, 2009

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)

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