General MedicationsORALStandard

LOPERAMIDE HYDROCHLORIDE

Standard Dose

2MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview LOPERAMIDE HYDROCHLORIDE is listed in Drugs@FDA under application 218122 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LOPERAMIDE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 2MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2023-09-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview LOPERAMIDE HYDROCHLORIDE is listed in Drugs@FDA under application 218122 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LOPERAMIDE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 2MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2023-09-05 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.