Drug application

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)

Drugs@FDA ANDA 079050 · CHARTWELL RX

Key facts

Drug name ROPINIROLE HYDROCHLORIDE
Active ingredients ROPINIROLE HYDROCHLORIDE
Application type ANDA
Application number 079050
Company CHARTWELL RX
Dosage forms TABLET, ORAL
Strength EQ 0.25MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 29, 2008

At a glance

  • 1–9 Submissions
  • 1–9 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

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