Granules receives USFDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets

30 Aug 2022 , 01:33 AM

Granules India announced today that the US Food Drug Administration US FDA has approved its Abbreviated New Drug Application ANDA for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release ER Tablets 600 mg60 mg and 1200 mg120 mg OTC It is bioequivalent to the reference listed drug product Mucinex D Extended-Release Tablets 600 mg60 mg and 1200 mg120 mg of RB Health US LLC Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets are used to loosen phlegm mucus and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive; temporarily relieve nasal congestion due to common cold hay fever upper respiratory allergies; temporarily restores freer breathing through the nose; promotes nasal andor sinus drainage; and temporarily relieves sinus congestion and pressure The Mucinex65039; D brand and store brands had combined US sales of approximately $71 million MAT for the most recent twelve months