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GUAIFENESIN

 
 
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

Safety Information
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…

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

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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