FDA Approval Activities for this Drug…

Delsym (Dextromethorphan Polistirex) Extended-Release Suspension Celltech Americas, NDA 18-658/S015 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Syrup; 2MG/5ML;10MG/5ML;30MG/5ML MYPHETANE DX Morton Grove 089681 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE Syrup; 2MG/5ML;10MG/5ML;30MG/5ML BROMFED-DM VERUM 088762 DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 15MG/5ML;6.25MG/5ML PROMETH W/ DEXTROMETHORPHAN ALPHARMA 040027 DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 15MG/5ML;6.25MG/5ML PROMETHAZINE HCL AND DEXTROMETHORPHAN HYDROBROMIDE HI TECH 088864 DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 15MG/5ML;6.25MG/5ML PROMETHAZINE W/ DEXTROMETHORPHAN Morton Grove Phenergan w/dextromethorphan (promethazine HCl & dextromethorphan hydrobromide) Syrup, Wyeth Pharmaceuticals | Delsym (dextromethorphan polistirex) Extended-Release Suspension, Celltech Pharma, Formulation Revision | Mucinex D (guaifenesin and pseudoephedrine HCl) Extended-release Bi-layer Tablets, Adams Respiratory Therapeutics, Package Change | Mucinex DM (guaifenesin and dextromethorphan) Extended-release Bi-layer Tablets, Adams Respiratory Therapeutics, Package Change | Delsym (dextromethorphan polistirex) ER Suspension, Celltech Pharma, Package Change

For the latest approval information, please see the main page.