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Lupin receives US FDA approval for Generic Norco tabs

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The product will be launched shortly

Lupin Somerset (also known as Novel Laboratories) has received final approval for its Hydrocodone Bitartrate and Acetaminophen tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg from the United States Food and Drug Administration (FDA) to market a generic equivalent of Allergan Sales’ Norco tablets 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg. The company shall launch the product shortly.

Lupin’s Hydrocodone Bitartrate and Acetaminophen tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg are the AA rated generic equivalent of Allergan Sales LLC’s Norco tablets 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg. It is indicated for the relief of moderate to moderately severe pain.

Hydrocodone Bitartrate and Acetaminophen tablets USP 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg had US sales of USD 849.5 million (IMS MAT September 2016).

EP News Bureau

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