Orange Book product

HALOPERIDOL DECANOATE EQ 100MG BASE/ML

Orange Book ANDA 074893 · FRESENIUS KABI USA LLC · Prescription

Key facts

Proprietary name HALOPERIDOL DECANOATE
Active ingredients HALOPERIDOL DECANOATE
Strength EQ 100MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA074893
Applicant holder FRESENIUS KABI USA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AO
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 19, 1997

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)

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