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US FDA approves Granules ANDA for Guaifenesin ER tablets

Granules now have a total of 51 ANDA approvals from the US FDA (49 Final approvals and 2 tentative approvals).

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Hyderabad: Granules India Limited announced on Friday 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 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.

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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 and/or sinus drainage; and temporarily relieves sinus congestion and pressure, a company release said.

Granules now have a total of 51 ANDA approvals from the US FDA (49 Final approvals and 2 tentative approvals).

The Mucinex D brand and store brands had combined U.S. sales of approximately USD 71 million MAT for the most recent twelve months, the release added.

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