Orange Book product

FENTANYL CITRATE AND DROPERIDOL 2.5MG/ML;EQ 0.05MG BASE/ML

Orange Book ANDA 072027 · ASTRAZENECA LP · Discontinued

Key facts

Proprietary name FENTANYL CITRATE AND DROPERIDOL
Active ingredients DROPERIDOL, FENTANYL CITRATE
Strength 2.5MG/ML;EQ 0.05MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA072027
Applicant holder ASTRAZENECA LP
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 13, 1989

At a glance

  • None 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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