Drug application

ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE)

Drugs@FDA ANDA 201576 · DR REDDYS LABS LTD

Key facts

Drug name ROPINIROLE HYDROCHLORIDE
Active ingredients ROPINIROLE HYDROCHLORIDE
Application type ANDA
Application number 201576
Company DR REDDYS LABS LTD
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength EQ 2MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Jun 6, 2012

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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