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Details for Generic Name: loperamide hydrochloride

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Summary for Generic Name: loperamide hydrochloride

Drug Master File Entries: see list10
Suppliers: see list21
Therapeutic Class:Gastrointestinal Agents

Clinical Trials for: loperamide hydrochloride

Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Status: Completed Condition: Diarrhea

Efficacy of Loperamide in Treating Patients for C. Difficile Colitis and Diarrheal Disease of Unknown Cause Associated With Antibiotic Therapy
Status: Recruiting Condition: Antibiotic Associated Diarrhea; Clostridium Difficile

Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Status: Recruiting Condition: Fecal Incontinence

Loperamide Grapefruit Juice Interaction PK Trial
Status: Completed Condition: Drug Interaction

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Status: Recruiting Condition: Rectal Cancer; Ulcerative Colitis; Short Bowel Syndrome

Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Status: Not yet recruiting Condition: Dehydration, Diverting Ileostomy, Loperamide

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.
Status: Completed Condition: Intestinal Obstruction

A Comparison of Three Medications to Treat Diarrhea in Adults.
Status: Completed Condition: Diarrhea

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects
Status: Completed Condition: Intestinal Obstruction

Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea
Status: Completed Condition: Travelers' Diarrhea

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mcneil Cons
loperamide hydrochloride
SOLUTION;ORAL019487Mar 1, 1988OTCYes<disabled><disabled>
Banner Pharmacaps
loperamide hydrochloride
CAPSULE;ORAL021855Aug 4, 2005OTCNo<disabled><disabled>
Janssen Pharms
loperamide hydrochloride
SOLUTION;ORAL019037Jul 31, 1984DISCNNo<disabled><disabled>
loperamide hydrochloride
TABLET;ORAL076497Jun 10, 2003OTCNo<disabled><disabled>
loperamide hydrochloride
CAPSULE;ORAL073192Apr 30, 1992RXNo<disabled><disabled>
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Preferred citation:

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

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