Hyderabad: Granules India Limited announced on Friday that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Guaif enesin and Pseudoe phedrine Hydrochlo- ride Extend ed-Release (ER) Tablets, 600 mg/60 mg and 1200 mg/120 mg (OTC).
It is bioequivalent to the reference listed drug product, Mucinex D Extended-Release Tablets, 600 mg/60 mg, and 1200 mg/120 mg, of RB Health (US) LLC. Guaifenesin and Pseudoephedrine Hydrochloride ER Tab lets 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, pro- motes nasal and/or sinus drainage; and temporarily relieves sinus congestion and pressure, a company release said.
