Orange Book product

FLUTAMIDE 125MG

Orange Book ANDA 075780 · CIPLA LTD · Discontinued

Key facts

Proprietary name FLUTAMIDE
Active ingredients FLUTAMIDE
Strength 125MG
Dosage form CAPSULE
Route ORAL
Application ANDA075780
Applicant holder CIPLA LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 19, 2001

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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