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Last Updated: February 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021140


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NDA 021140 describes IMODIUM MULTI-SYMPTOM RELIEF, which is a drug marketed by J And J Consumer Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the IMODIUM MULTI-SYMPTOM RELIEF profile page.

The generic ingredient in IMODIUM MULTI-SYMPTOM RELIEF is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 021140
Suppliers and Packaging for NDA: 021140
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-338 50580-338-12 2 BLISTER PACK in 1 CARTON (50580-338-12) > 6 TABLET in 1 BLISTER PACK
IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 50580-338 50580-338-18 3 BLISTER PACK in 1 CARTON (50580-338-18) > 6 TABLET in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021140
Tradename Dosage Ingredient NDA Submissiondate
IMODIUM MULTI-SYMPTOM RELIEF TABLET;ORAL loperamide hydrochloride; simethicone 021140 2004-12-29

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength2MG;125MG
Approval Date:Nov 30, 2000TE:RLD:Yes

Expired US Patents for NDA 021140

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140-001 Nov 30, 2000   Start Trial   Start Trial
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140-001 Nov 30, 2000   Start Trial   Start Trial
J And J Consumer Inc IMODIUM MULTI-SYMPTOM RELIEF loperamide hydrochloride; simethicone TABLET;ORAL 021140-001 Nov 30, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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