Drug application

QUETIAPINE FUMARATE (QUETIAPINE FUMARATE)

Drugs@FDA ANDA 201504 · ALKEM LABS LTD

Key facts

Drug name QUETIAPINE FUMARATE
Active ingredients QUETIAPINE FUMARATE
Application type ANDA
Application number 201504
Company ALKEM LABS LTD
Dosage forms TABLET, ORAL
Strength EQ 25MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Feb 12, 2013

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

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

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