Orange Book product

ASTRAMORPH PF 0.5MG/ML

Orange Book ANDA 071050 · FRESENIUS KABI USA LLC · Discontinued

Key facts

Proprietary name ASTRAMORPH PF
Active ingredients MORPHINE SULFATE
Strength 0.5MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA071050
Applicant holder FRESENIUS KABI USA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 7, 1986

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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