Orange Book product

MORPHINE SULFATE 10MG/5ML

Orange Book ANDA 203518 · TRIS PHARMA INC · Discontinued

Key facts

Proprietary name MORPHINE SULFATE
Active ingredients MORPHINE SULFATE
Strength 10MG/5ML
Dosage form SOLUTION
Route ORAL
Application ANDA203518
Applicant holder TRIS PHARMA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 12, 2015

At a glance

  • 1–9 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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