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FDA Approval Activities for this Drug…
Mucinex (Guaifenesin) Extended-Release Tablets, 1200 mg, OTC Adams , NDA 21-282/S1 12/18/02 1/29/03 Mucinex (Guaifenesin) Extended-Release Tablets, 600 mg, OTC Adams , NDA 21-282 Mucinex D (guaifenesin and pseudoephedrine HCl) Extended-release Tablets, Adams Respiratory | 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 | Mucinex D (guaifenesin & pseudoephedrine HCl) Extended-release Bi-layer Tablets, Adams Respiratory, Package Change | Mucinex DM Extended-release Bi-layer Tablets, Adams Respiratory Ther., Package Change | Mucinex (Guaifenesin) Extended Release Bi-Layer Tablets, Adams Respiratory Terapeutics, Package Change | Mucinex (guaifenesin) Extended Release Bi-Layer Tablets, Adams Respiratory, Labeling Revision | Mucinex (guaifenesin) Extended Release Bi-layer Tablets, Adams Respiratory Therapeutics, Formulation Revision | Mucinex D (guaifenesin, pseudoephedrine HCl and 1200 mg guaifenesin/120 mg pseudoephedrine HCl) Extended Release Bi-layer Tablets, Adams Respiratory Therapeutics, Formulation Revision | Mucinex DM (guaifenesin, dextromethorphan HBr and guaifenesin dextromethorphan HBr) Extended Release Bi-layer Tablets, Adams Respiratory Therapeutics, Formulation Revision | Mucinex (guaifenesin) Extended-Release Tablets, Adams Respiratory Therapeutics, Package Change | Mucinex DM (guaifenesin and dextromethorphan) Extended-Release Tablets, Reckitt Benckiser, Package Change | Mucinex D (guaifenesin and pseudoephedrine hydrochloride) Extended-Release Tablets, Reckitt Benckiser, Inc., Manufacturing Change or Addition | Guaifenesin Extended-Release Tablets, Perrigo R&D Co., Approval
  
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