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Granules Indiahas received approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Guaifenesin and Pseudoephedrine Hydrochloride Extended-Release (ER) Tablets.
The approved product is bioequivalent to the reference listed drug product, Mucinex D Extended-Release Tablets 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, among others.
The Mucinex D brand and store brands had combined U.S. sales of approximately $71 million for the most recent twelve months, the Hyderabad-based Granules said in a release.
Granules now has a total of 51 ANDA approvals from the US FDA.
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