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Details for Generic Name: loperamide hydrochloride

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Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by Mcneil Cons, Mcneil Ped, Banner Life Sciences, Mylan, Roxane, Sandoz, Teva, Janssen Pharms, Alpharma Us Pharms, Duramed Pharms Barr, Hi Tech Pharma, Perrigo, Watson Labs, Wockhardt, Perrigo R And D, Mcneil, Able, Contract Pharmacal, LNK, Ohm Labs, and Ranbaxy, and is included in thirty-one NDAs. There are three 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. Twenty-one suppliers are listed for this compound.

Summary for Generic Name: loperamide hydrochloride

Drug Master File Entries: see list10
Suppliers: see list21
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

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
loperamide hydrochloride
CAPSULE;ORAL072993-001Aug 28, 1992DISCNNo<disabled><disabled>
loperamide hydrochloride
TABLET;ORAL075232-001Jan 6, 2000OTCNo<disabled><disabled>
loperamide hydrochloride; simethicone
TABLET, CHEWABLE;ORAL076029-001Aug 30, 2002OTCNo<disabled><disabled>
Mcneil Cons
loperamide hydrochloride
SOLUTION;ORAL019487-001Mar 1, 1988OTCYes<disabled><disabled>
Mcneil Cons
loperamide hydrochloride; simethicone
TABLET;ORAL021140-001Nov 30, 2000OTCYes6,103,260<disabled>Y<disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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