MAR 12, 2026 · REGULATORY APPROVAL
FDA approval: Promethazine Hydrochloride AND Dextromethorphan Hydrobromide
U.S. Food and Drug Administration
FDA approval of a fixed-dose combination syrup; this is a regulatory action confirming manufacturing and quality standards, not a clinical efficacy determination.
Insufficient InformationHetero Labs LTD IIIPromethazine Hydrochloride AND Dextromethorphan Hydrobromide
Reported
Promethazine hydrochloride concen…6.25 mg/5 mL
Dextromethorphan hydrobromide con…15 mg/5 mL
Approval date2026-03-12