Drug application

DEXTROMETHORPHAN POLISTIREX (DEXTROMETHORPHAN POLISTIREX)

Drugs@FDA ANDA 218417 · AUROBINDO PHARMA LTD

Key facts

Drug name DEXTROMETHORPHAN POLISTIREX
Active ingredients DEXTROMETHORPHAN POLISTIREX
Application type ANDA
Application number 218417
Company AUROBINDO PHARMA LTD
Dosage forms SUSPENSION, EXTENDED RELEASE, ORAL
Strength EQ 30MG HYDROBROMIDE/5ML
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Apr 15, 2026

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None 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

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