Orange Book product

FENTANYL-100 100MCG/HR

Orange Book ANDA 077775 · NOVEN PHARMACEUTICALS INC · Discontinued

Key facts

Proprietary name FENTANYL-100
Active ingredients FENTANYL
Strength 100MCG/HR
Dosage form FILM, EXTENDED RELEASE
Route TRANSDERMAL
Application ANDA077775
Applicant holder NOVEN PHARMACEUTICALS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 16, 2009

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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