Drug application

LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)

Drugs@FDA ANDA 218122 · AUROBINDO PHARMA LTD

Key facts

Drug name LOPERAMIDE HYDROCHLORIDE
Active ingredients LOPERAMIDE HYDROCHLORIDE
Application type ANDA
Application number 218122
Company AUROBINDO PHARMA LTD
Dosage forms CAPSULE, ORAL
Strength 2MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Sep 5, 2023

At a glance

  • 1–9 Submissions
  • 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

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