Drug application

MORPHINE SULFATE (MORPHINE SULFATE)

Drugs@FDA NDA 022207 · HIKMA PHARMS

Key facts

Drug name MORPHINE SULFATE
Active ingredients MORPHINE SULFATE
Application type NDA
Application number 022207
Company HIKMA PHARMS
Dosage forms TABLET, ORAL
Strength 15MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 7 - Drug Already Marketed without Approved NDA
Latest submission status date Mar 17, 2008

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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