Drug application

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)

Drugs@FDA ANDA 200462 · AUROBINDO PHARMA USA

Key facts

Drug name ROPINIROLE HYDROCHLORIDE
Active ingredients ROPINIROLE HYDROCHLORIDE
Application type ANDA
Application number 200462
Company AUROBINDO PHARMA USA
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength EQ 2MG BASE
Marketing status Discontinued
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Oct 15, 2012

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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