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Loperamide hydrochloride - Generic Drug Details

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Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by Teva, Able, Wockhardt, Perrigo, Janssen Pharms, Mylan, J And J Consumer Inc, Aurobindo Pharma Ltd, Hi Tech Pharma, Contract Pharmacal, Bionpharma Inc, Watson Labs, Roxane, Alpharma Us Pharms, Duramed Pharms Barr, Ohm Labs, Perrigo R And D, Sandoz, LNK, and Sun Pharm Inds Ltd, and is included in thirty-two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for loperamide hydrochloride. One hundred and twelve suppliers are listed for this compound.

Summary for Generic Name: loperamide hydrochloride

Tradenames:6
Patents:2
Applicants:20
NDAs:32
Drug Master File Entries: see list10
Suppliers / Packaging: see list112
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: loperamide hydrochloride

Ingredient-typeBenzodiazepines
Drug ClassOpioid Agonist
Benzodiazepine
Mechanism of ActionOpioid Agonists

Clinical Trials for: loperamide hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hi Tech Pharma
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
SOLUTION;ORAL074352-001Nov 17, 1995OTCNo<disabled><disabled>
J And J Consumer Inc
IMODIUM MULTI-SYMPTOM RELIEF
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL020606-001Jun 26, 1996OTCYes<disabled><disabled>
Roxane
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
SOLUTION;ORAL073079-001Apr 30, 1992OTCNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: loperamide hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
IMODIUM A-D
loperamide hydrochloride
SOLUTION;ORAL019487-001Mar 1, 19883,714,159<disabled>
J And J Consumer Inc
IMODIUM A-D EZ CHEWS
loperamide hydrochloride
TABLET, CHEWABLE;ORAL020448-001Jul 24, 19975,489,436<disabled>
Janssen Pharms
IMODIUM
loperamide hydrochloride
SOLUTION;ORAL019037-001Jul 31, 19843,714,159<disabled>
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