General MedicationsORALStandard

PROPAFENONE HYDROCHLORIDE

Standard Dose

325MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview PROPAFENONE HYDROCHLORIDE is listed in Drugs@FDA under application 214184 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PROPAFENONE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 325MG Sponsor ZYDUS LIFESCIENCES Submission history Latest submission status date: 2021-04-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview PROPAFENONE HYDROCHLORIDE is listed in Drugs@FDA under application 214184 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PROPAFENONE HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 325MG Sponsor ZYDUS LIFESCIENCES Submission history Latest submission status date: 2021-04-21 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.