Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Mucinex DM Extended-release Bi-layer Tablets, Adams Respiratory Ther., Package Change | Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup, Vintage Pharma, Approval | Mucinex DM (guaifenesin, dextromethorphan HBr and guaifenesin dextromethorphan HBr) Extended Release Bi-layer Tablets, Adams Respiratory Therapeutics, Formulation Revision | Delsym (dextromethorphan polistirex) Extended-Release Suspension, Adams Respiratory, Formulation Revision | Phenergan with Dextromethorphan (promethazine hydrochloride, dextromethorphan hydrobromide) Syrup, ANI Pharma, Manufacturing Change or Addition | Delsym (dextromethorphan polistirex), Extended-Release Suspension, Adams Respiratory Therapy, Labeling Revision | Mucinex DM (guaifenesin and dextromethorphan) Extended-Release Tablets, Reckitt Benckiser, Package Change ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2009 Betterchem.com