NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
CIPRO XR (ciprofloxacin; ciprofloxacin hydrochloride) by R-Pharm US is [see ] . Approved for infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: acute otitis media (aom) in pediatric patients (age 6 months, older) with tympanostomy tubes due to staphylococcus aureus, streptococcus pneumoniae and 3 more indications. First approved in 2003.
Drug data last refreshed 18h ago
Mechanism of Action
[see ] . Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.
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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.