General MedicationsORALGeneric

DRONEDARONE HYDROCHLORIDE

Standard Dose

EQ 400MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview DRONEDARONE HYDROCHLORIDE is listed in Drugs@FDA under application 205904 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DRONEDARONE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 400MG BASE Sponsor LUPIN Submission history Latest submission status date: 2024-01-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview DRONEDARONE HYDROCHLORIDE is listed in Drugs@FDA under application 205904 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DRONEDARONE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 400MG BASE Sponsor LUPIN Submission history Latest submission status date: 2024-01-31 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.