Drug application

FENTANYL-12 (FENTANYL)

Drugs@FDA ANDA 202097 · KINDEVA

Key facts

Drug name FENTANYL-12
Active ingredients FENTANYL
Application type ANDA
Application number 202097
Company KINDEVA
Dosage forms FILM, EXTENDED RELEASE, TRANSDERMAL
Strength 12.5MCG/HR
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Nov 4, 2016

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • No FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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