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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 | Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser, Inc., Labeling Revision | Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser Inc., Labeling Revision | Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser, Inc., Manufacturing Change or Addition | Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup, Amneal Pharmaceuticals, Approval | Dextromethorphan Polistirex Extended-Release Oral Suspension, Tris Pharma, Inc., Tentative Approval | Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser, Inc., Labeling Revision
  
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