BELIX

Post-LOE

diphenhydramine hydrochloride

Gland Pharma

ANDAORALELIXIR

Approved

Oct 1983

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

BELIX (diphenhydramine hydrochloride) by Gland Pharma is clinical pharmacology diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Approved for common cold symptoms: cough due to minor throat & bronchial irritation helps loosen phlegm (mucus), thin bronchial secretions to: drain bronchial tubes make coughs more productive. First approved in 1983.

Drug data last refreshed Yesterday

Mechanism of Action

CLINICAL PHARMACOLOGY Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. Diphenhydramine hydrochloride in the injectable form has a rapid onset of…

Indications (2)

common cold symptoms: cough due to minor throat & bronchial irritation helps loosen phlegm (mucus)

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (5)

NCT03424135Phase 1Completed

A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions

Started Mar 2018

60 enrolled

Clinical Pharmacology

NCT03396250Phase 1Completed

A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects

Started Feb 2018

36 enrolled

Pain

NCT01666678Phase 1Completed

Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination

Started Jan 2012

32 enrolled

Therapeutic Equivalence

NCT00577031Phase 4Completed

OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.

Started Feb 2008

205 enrolled

Colorectal Cancer

NCT00662337Phase 1Completed

Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride

Started Oct 2006

36 enrolled

Nasal Congestion