Drug application

DEXCHLORPHENIRAMINE MALEATE (DEXCHLORPHENIRAMINE MALEATE)

Drugs@FDA ANDA 088251 · PAI HOLDINGS PHARM

Key facts

Drug name DEXCHLORPHENIRAMINE MALEATE
Active ingredients DEXCHLORPHENIRAMINE MALEATE
Application type ANDA
Application number 088251
Company PAI HOLDINGS PHARM
Dosage forms SYRUP, ORAL
Strength 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
TE codes AA
Reference listed drug Yes
Latest submission status date Mar 23, 1984

At a glance

  • 1–9 Submissions
  • 10–99 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