NDAORALSYRUP
Approved
Apr 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMBENYL is a fixed-dose oral syrup combining bromodiphenhydramine hydrochloride (an antihistamine) and codeine phosphate (an opioid antitussive), approved in 1954 for cough suppression and symptom relief. The combination leverages the anticholinergic and sedating properties of the antihistamine paired with the antitussive potency of codeine to address productive and non-productive cough. This product represents a legacy formulation from the era before modern cough and cold regulations.
LOE Approaching
With LOE approaching and minimal current market activity, this product presents limited growth opportunities and likely operates with a small, legacy-focused team focused on supply continuity rather than expansion.
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 minimal career advancement and limited visibility due to its legacy status, approaching loss of exclusivity, and low market activity. Roles are custodial in nature, focused on compliance, supply continuity, and managing decline rather than growth or innovation.
Brand Manager (legacy/custodial)Regulatory Affairs Specialist
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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.