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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 019487


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NDA 019487 describes IMODIUM A-D, which is a drug marketed by J And J Consumer Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the IMODIUM A-D profile page.

The generic ingredient in IMODIUM A-D is loperamide hydrochloride. There are eleven drug master file entries for this compound. One hundred and four suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride profile page.
Summary for 019487
Tradename:IMODIUM A-D
Applicant:J And J Consumer Inc
Ingredient:loperamide hydrochloride
Patents:0
Pharmacology for NDA: 019487
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 019487
Suppliers and Packaging for NDA: 019487
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487 NDA Kenvue Brands LLC 50580-134 50580-134-04 120 mL in 1 BOTTLE (50580-134-04)
IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487 NDA Kenvue Brands LLC 50580-134 50580-134-08 240 mL in 1 BOTTLE (50580-134-08)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;ORALStrength1MG/5ML
Approval Date:Mar 1, 1988TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength1MG/7.5ML
Approval Date:Jul 8, 2004TE:RLD:Yes

Expired US Patents for NDA 019487

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487-001 Mar 1, 1988 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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