Orange Book product

BROMFENAC SODIUM EQ 0.09% ACID

Orange Book ANDA 201211 · COASTAL PHARMACEUTICALS · Discontinued

Key facts

Proprietary name BROMFENAC SODIUM
Active ingredients BROMFENAC SODIUM
Strength EQ 0.09% ACID
Dosage form SOLUTION/DROPS
Route OPHTHALMIC
Application ANDA201211
Applicant holder COASTAL PHARMACEUTICALS
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 11, 2011

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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