Drug application

FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)

Drugs@FDA ANDA 218769 · HETERO LABS LTD III

Key facts

Drug name FLUPHENAZINE HYDROCHLORIDE
Active ingredients FLUPHENAZINE HYDROCHLORIDE
Application type ANDA
Application number 218769
Company HETERO LABS LTD III
Dosage forms TABLET, ORAL
Strength 1MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Nov 18, 2025

At a glance

  • 1–9 Submissions
  • 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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