Orange Book product

PROCHLORPERAZINE MALEATE EQ 5MG BASE

Orange Book ANDA 040207 · DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC · Discontinued

Key facts

Proprietary name PROCHLORPERAZINE MALEATE
Active ingredients PROCHLORPERAZINE MALEATE
Strength EQ 5MG BASE
Dosage form TABLET
Route ORAL
Application ANDA040207
Applicant holder DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 1, 1997

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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