Drug application

HALOPERIDOL (HALOPERIDOL LACTATE)

Drugs@FDA ANDA 078347 · MYLAN LABS LTD

Key facts

Drug name HALOPERIDOL
Active ingredients HALOPERIDOL LACTATE
Application type ANDA
Application number 078347
Company MYLAN LABS LTD
Dosage forms INJECTABLE, INJECTION
Strength EQ 5MG BASE/ML
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Sep 14, 2009

At a glance

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

Browse all Drugs@FDA applications