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FDA approves Lupin’s hydrocodone bitartrate, acetaminophen tablets


SILVER SPRING, Md. — The Food and Drug Administration has approved a generic of Mikart’s hydrocodone bitartrate and acetaminophen tablets from Gavis Pharmaceuticals, Lupin’s U.S. subsidiary, the company announced Thursday. 


Lupin’s generic will be available in 5 mg hydrocodone bitartrate/300 mg acetaminophen, 7.5 mg hydrocodone bitartrate /300 mg acetaminophen and 10 mg hydrocodone bitartrate/300 mg acetaminophen. The drug had U.S. sales of $89.6 million, according to QuintilesIMS data for the 12 months ended September 2016. 


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