General MedicationsORALGeneric

ROPINIROLE HYDROCHLORIDE

Standard Dose

EQ 3MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview ROPINIROLE HYDROCHLORIDE is listed in Drugs@FDA under application 200462 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ROPINIROLE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE Sponsor AUROBINDO PHARMA USA Submission history Latest submission status date: 2015-10-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview ROPINIROLE HYDROCHLORIDE is listed in Drugs@FDA under application 200462 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ROPINIROLE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE Sponsor AUROBINDO PHARMA USA Submission history Latest submission status date: 2015-10-16 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.