NDAINHALATIONAEROSOL, METERED
Approved
Sep 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
BRONCHO SALINE (sodium chloride) by Fresenius Kabi is clinical pharmacology 3% and 5% sodium chloride injection, usp has value as a source of water and electrolytes. First approved in 1992.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BRONCHO SALINE is a 3% and 5% sodium chloride inhalation aerosol indicated for bronchial hygiene and airway clearance. It acts as an osmotic agent to mobilize secretions in the respiratory tract. The product is administered via metered-dose inhaler for direct pulmonary delivery.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), indicating contraction phase and downsizing of commercial infrastructure.
Mechanism of Action
CLINICAL PHARMACOLOGY 3% and 5% Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride
Started Mar 2013
207 enrolled
Pneumonia
Tetraspan 6 Percent (%) Combined With Sterofundin ISO Versus Albumin 5 Percent (%) Combined With Sodium Chloride (NaCL)
Started Nov 2009
2 enrolled
Renal Insufficiency
A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion
Started Sep 2008
176 enrolled
Healthy
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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.