Drug application

PALIPERIDONE PALMITATE (PALIPERIDONE PALMITATE)

Drugs@FDA ANDA 216674 · ACCORD HLTHCARE INC

Key facts

Drug name PALIPERIDONE PALMITATE
Active ingredients PALIPERIDONE PALMITATE
Application type ANDA
Application number 216674
Company ACCORD HLTHCARE INC
Dosage forms INJECTABLE, SUSPENSION, EXTENDED RELEASE
Strength 156MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date May 16, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None 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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