FDA
NDA 021282 (label) INN (GUAIFENESIN) MUCINEX (RECKITT BENCKISER) APPROVAL= AP YEAR= 2002
NDA 021585 (label) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) MUCINEX D (RECKITT BENCKISER) APPROVAL= AP YEAR= 2004
NDA 021620 (label) INN (DEXTROMETHORPHAN HYDROBROMIDE ; GUAIFENESIN) MUCINEX DM (RECKITT BENCKISER) APPROVAL= AP YEAR= 2004
NDA 078912 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (PERRIGO R AND D) APPROVAL= AP YEAR= 2011
NDA 205474 (label) INN (GUAIFENESIN ; HYDROCODONE BITARTRATE) OBREDON (SOVEREIGN PHARMS) APPROVAL= AP YEAR= 2014 DISCONTINUED
NDA 022279 (label) INN (GUAIFENESIN ; HYDROCODONE BITARTRATE ; PSEUDOEPHEDRINE HYDROCHLORIDE) HYCOFENIX (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 022424 (label) INN (GUAIFENESIN ; HYDROCODONE BITARTRATE) FLOWTUSS (CHARTWELL RX) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 091071 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015
NDA 091009 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015
NDA 091070 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (ACTAVIS LABS FL) APPROVAL= AP YEAR= 2015
NDA 208369 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (DR REDDYS) APPROVAL= AP YEAR= 2017
NDA 206941 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2017
NDA 209215 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (GUARDIAN DRUG) APPROVAL= AP YEAR= 2017
NDA 209692 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018
NDA 207602 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (PERRIGO R AND D) APPROVAL= AP YEAR= 2018
NDA 208085 (label) INN (GUAIFENESIN ; HYDROCODONE BITARTRATE) XTRELUS (ECI PHARMS LLC) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 207342 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018
NDA 209254 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (OHM LABS INC) APPROVAL= AP YEAR= 2018
NDA 210453 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2019
NDA 212542 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (SUN PHARM INDS INC) APPROVAL= AP YEAR= 2020
NDA 213203 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2020
NDA 213420 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (GRANULES) APPROVAL= AP YEAR= 2020
NDA 214781 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (SUN PHARM) APPROVAL= AP YEAR= 2021
NDA 214407 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (L PERRIGO CO) APPROVAL= AP YEAR= 2022
NDA 215932 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (DR REDDYS) APPROVAL= AP YEAR= 2022
NDA 216082 (pdf not found) INN (GUAIFENESIN ; PSEUDOEPHEDRINE HYDROCHLORIDE) GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE (GRANULES) APPROVAL= AP YEAR= 2022 DISCONTINUED
NDA 217340 (pdf not found) INN (DEXTROMETHORPHAN HYDROBROMIDE ; GUAIFENESIN) GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (DR REDDYS) APPROVAL= AP YEAR= 2023
NDA 217780 (pdf not found) INN (GUAIFENESIN) GUAIFENESIN (MARKSANS PHARMA) APPROVAL= AP YEAR= 2023
NDA 217338 (label) INN (DEXTROMETHORPHAN HYDROBROMIDE ; GUAIFENESIN ; NAPROXEN SODIUM) MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM (RECKITT BENCKISER) APPROVAL= AP YEAR= 2025