Orange Book product

HALOPERIDOL EQ 2MG BASE/ML

Orange Book ANDA 073037 · PHARMACEUTICAL ASSOCIATES INC · Prescription

Key facts

Proprietary name HALOPERIDOL
Active ingredients HALOPERIDOL LACTATE
Strength EQ 2MG BASE/ML
Dosage form CONCENTRATE
Route ORAL
Application ANDA073037
Applicant holder PHARMACEUTICAL ASSOCIATES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Feb 26, 1993

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Browse all Orange Book products