Drug application

MORPHINE SULFATE (MORPHINE SULFATE)

Drugs@FDA ANDA 212451 · ALKEM LABS LTD

Key facts

Drug name MORPHINE SULFATE
Active ingredients MORPHINE SULFATE
Application type ANDA
Application number 212451
Company ALKEM LABS LTD
Dosage forms TABLET, ORAL
Strength 15MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Dec 3, 2020

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents
  • Yes FDA letters on file
  • No 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:

Browse all Drugs@FDA applications