Application Information

This drug has been submitted to the FDA under the reference 088811/001.

Names and composition

"BROMFED-DM" is the commercial name of a drug composed of BROMPHENIRAMINE MALEATE and DEXTROMETHORPHAN HYDROBROMIDE and PSEUDOEPHEDRINE HYDROCHLORIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
088811/001 BROMFED-DM BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML
089681/001 BROMFED-DM BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019279/001 DIMETANE-DX BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
088722/001 BROMANATE DM BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML
088811/001 BROMFED-DM BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML
089681/001 BROMFED-DM BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML
202940/001 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML
203375/001 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML
205112/001 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML
205292/001 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP/ORAL 2MG per 5ML and 10MG per 5ML and 30MG per 5ML

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