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Last Updated: August 17, 2022

Details for New Drug Application (NDA): 017694


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NDA 017694 describes IMODIUM, which is a drug marketed by J And J Consumer Inc and Janssen Pharms and is included in eight NDAs. Additional details are available on the IMODIUM profile page.

The generic ingredient in IMODIUM is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 017694
Tradename:IMODIUM
Applicant:J And J Consumer Inc
Ingredient:loperamide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 017694

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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