Application Information

This drug has been submitted to the FDA under the reference 040649/001.

Names and composition

"PROMETHAZINE DM" is the commercial name of a drug composed of DEXTROMETHORPHAN HYDROBROMIDE and PROMETHAZINE HYDROCHLORIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
040649/001 PROMETHAZINE DM DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
011265/002 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
040027/001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML
040649/001 PROMETHAZINE DM DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML
088762/001 PROMETH W/ DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML
088864/001 PROMETHAZINE W/ DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML
088913/001 PHERAZINE DM DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML
090575/001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML
091687/001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP/ORAL 15MG per 5ML and 6.25MG per 5ML

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