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Details for New Drug Application (NDA): 020448

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NDA 020448 describes IMODIUM A-D EZ CHEWS, which is a drug marketed by J And J Consumer Inc and is included in one NDA. There is one patent protecting this drug. Additional details are available on the IMODIUM A-D EZ CHEWS profile page.

The generic ingredient in IMODIUM A-D EZ CHEWS is loperamide hydrochloride. There are eleven drug master file entries for this compound. One hundred and seventeen suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride profile page.

Summary for NDA: 020448

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength2MG
Approval Date:Jul 24, 1997TE:RLD:Yes
Patent:6,814,978Patent Expiration:Aug 26, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020448

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
loperamide hydrochloride
TABLET, CHEWABLE;ORAL020448-001Jul 24, 19975,489,436► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.