Orange Book product

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE

Orange Book ANDA 214987 · GLENMARK PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Active ingredients BRIMONIDINE TARTRATE, TIMOLOL MALEATE
Strength 0.2%;EQ 0.5% BASE
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA214987
Applicant holder GLENMARK PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 16, 2024

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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