Orange Book product

SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML

Orange Book NDA 019050 · RISING PHARMA HOLDINGS INC · Prescription

Key facts

Proprietary name SUFENTA PRESERVATIVE FREE
Active ingredients SUFENTANIL CITRATE
Strength EQ 0.05MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application NDA019050
Applicant holder RISING PHARMA HOLDINGS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date May 4, 1984

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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