Orange Book product

FENTANYL-75 75MCG/HR

Orange Book ANDA 076709 · ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name FENTANYL-75
Active ingredients FENTANYL
Strength 75MCG/HR
Dosage form FILM, EXTENDED RELEASE
Route TRANSDERMAL
Application ANDA076709
Applicant holder ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 20, 2007

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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