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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Harvard Business School

Last Updated: February 23, 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. Ninety-nine 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
Formulation / Manufacturing:see details
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 Johnson & Johnson Consumer Inc. 50580-134 50580-134-04 120 mL in 1 BOTTLE (50580-134-04)
IMODIUM A-D loperamide hydrochloride SOLUTION;ORAL 019487 NDA Johnson & Johnson Consumer Inc. 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

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Serving leading biopharmaceutical companies globally:

Express Scripts

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