General MedicationsORALGeneric

IMODIUM

LOPERAMIDE HYDROCHLORIDE

Standard Dose

2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview IMODIUM is listed in Drugs@FDA under application 017694 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient LOPERAMIDE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor J AND J CONSUMER INC Submission history Latest submission status date: 2016-11-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview IMODIUM is listed in Drugs@FDA under application 017694 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient LOPERAMIDE HYDROCHLORIDE Form and strength CAPSULE;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor J AND J CONSUMER INC Submission history Latest submission status date: 2016-11-03 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.