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General MedicationsORALStandard

ROPINIROLE HYDROCHLORIDE

ROPINIROLE HYDROCHLORIDE

Standard Dose
EQ 12MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ROPINIROLE HYDROCHLORIDE is listed in Drugs@FDA under application 217862 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ROPINIROLE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE Sponsor ELITE LABS INC Submission history Latest submission status date: 2025-11-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview ROPINIROLE HYDROCHLORIDE is listed in Drugs@FDA under application 217862 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ROPINIROLE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE Sponsor ELITE LABS INC Submission history Latest submission status date: 2025-11-10 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.