Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.