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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. There is one patent protecting this drug. 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. One supplier is listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.

Summary for NDA: 021140

Tradename:
IMODIUM MULTI-SYMPTOM RELIEF
Applicant:
J And J Consumer Inc
Ingredient:
loperamide hydrochloride; simethicone
Patents:1
Formulation / Manufacturing:see details

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

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength2MG;125MG
Approval Date:Nov 30, 2000TE:RLD:Yes
Patent:6,103,260Patent Expiration:Jul 17, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book 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;ORAL021140-001Nov 30, 20005,248,505► subscribe
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET;ORAL021140-001Nov 30, 20005,612,054► subscribe
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