NDAORALSYRUP
Approved
Apr 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 6h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMBENYL is an oral syrup combining bromodiphenhydramine hydrochloride (an antihistamine) and codeine phosphate (an opioid cough suppressant), approved in 1954. The fixed-dose combination targets cough and upper respiratory symptoms through dual mechanism action. This product represents a legacy small-molecule formulation typical of mid-20th century respiratory therapeutics.
LOE Approaching
LOE-approaching status indicates declining team investment; career roles are consolidating around generic transition management and stakeholder retention.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on AMBENYL offers limited career growth in a declining product with zero linked job postings and diminishing commercial investment. Roles are concentrated on legacy management, generic transition planning, and stakeholder communication rather than expansion or innovation.
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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.