Drug application

FENTANYL (FENTANYL)

Drugs@FDA ANDA 202577 · MYLAN PHARMS INC

Key facts

Drug name FENTANYL
Active ingredients FENTANYL
Application type ANDA
Application number 202577
Company MYLAN PHARMS INC
Dosage forms TABLET, BUCCAL
Strength 100MCG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Mar 4, 2015

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes 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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