General MedicationsORALStandard

ROPINIROLE HYDROCHLORIDE

Standard Dose

EQ 1MG 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 204022 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ROPINIROLE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 1MG BASE Sponsor ACCORD HLTHCARE Submission history Latest submission status date: 2025-03-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview ROPINIROLE HYDROCHLORIDE is listed in Drugs@FDA under application 204022 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ROPINIROLE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 1MG BASE Sponsor ACCORD HLTHCARE Submission history Latest submission status date: 2025-03-18 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.