Orange Book product

ALPHAGAN P 0.1%

Orange Book NDA 021770 · ABBVIE INC · Prescription

Key facts

Proprietary name ALPHAGAN P
Active ingredients BRIMONIDINE TARTRATE
Strength 0.1%
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application NDA021770
Applicant holder ABBVIE INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Aug 19, 2005

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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