NDAORALTABLET
Approved
Jun 2012
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
ADVIL (ibuprofen sodium) by GSK. Approved for pain. First approved in 2012.
Drug data last refreshed 20h ago
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Clinical Trials (3)
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects
Started Dec 2016
56 enrolled
Healthy Volunteers
Ibuprofen Sodium Tension Headache Study
Started Jun 2011
226 enrolled
Pain
Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.
Started Jul 2010
47 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.