Orange Book product

FLUOROURACIL 50MG/ML

Orange Book ANDA 040379 · FRESENIUS KABI USA LLC · Discontinued

Key facts

Proprietary name FLUOROURACIL
Active ingredients FLUOROURACIL
Strength 50MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA040379
Applicant holder FRESENIUS KABI USA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 15, 2000

At a glance

  • None 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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