Orange Book product

FLURBIPROFEN 100MG

Orange Book ANDA 074431 · GENUS LIFESCIENCES INC · Prescription

Key facts

Proprietary name FLURBIPROFEN
Active ingredients FLURBIPROFEN
Strength 100MG
Dosage form TABLET
Route ORAL
Application ANDA074431
Applicant holder GENUS LIFESCIENCES INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 31, 1995

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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