Orange Book product

MORPHINE SULFATE 50MG/ML

Orange Book NDA 202515 · HOSPIRA INC · Prescription

Key facts

Proprietary name MORPHINE SULFATE
Active ingredients MORPHINE SULFATE
Strength 50MG/ML
Dosage form INJECTABLE
Route INJECTION
Application NDA202515
Applicant holder HOSPIRA INC
Marketing status Prescription
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Apr 29, 2021

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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