Orange Book product

BRIMONIDINE TARTRATE 0.2%

Orange Book ANDA 091691 · REGCON HOLDINGS LLC · Prescription

Key facts

Proprietary name BRIMONIDINE TARTRATE
Active ingredients BRIMONIDINE TARTRATE
Strength 0.2%
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA091691
Applicant holder REGCON HOLDINGS LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AT
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 18, 2014

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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