Drug application

FENTANYL CITRATE PRESERVATIVE FREE (FENTANYL CITRATE)

Drugs@FDA ANDA 210762 · FRESENIUS KABI USA

Key facts

Drug name FENTANYL CITRATE PRESERVATIVE FREE
Active ingredients FENTANYL CITRATE
Application type ANDA
Application number 210762
Company FRESENIUS KABI USA
Dosage forms INJECTABLE, INJECTION
Strength EQ 0.05MG BASE/ML
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date May 3, 2019

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 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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