Orange Book product

PROCHLORPERAZINE MALEATE EQ 5MG BASE

Orange Book ANDA 218734 · AUROBINDO PHARMA LTD · Prescription

Key facts

Proprietary name PROCHLORPERAZINE MALEATE
Active ingredients PROCHLORPERAZINE MALEATE
Strength EQ 5MG BASE
Dosage form TABLET
Route ORAL
Application ANDA218734
Applicant holder AUROBINDO PHARMA LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 8, 2025

At a glance

  • 10–99 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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