Lupin receives USFDA approval for Hydrocodone Bitartrate, Acetaminophen Tablets

17 Nov 2016 Evaluate

Lupin’s US subsidiary, Gavis Pharmaceuticals LLC., USA (collectively Lupin) has received final approval for its Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5mg/300 mg, 7.5 mg/300 mg & 10 mg/300 mg from the United States Food and Drug Administration (USFDA) to market a generic equivalent of Mikart, Inc's Hydrocodone Bitartrate and Acetaminophen Tablets.

Lupin's said Tablets are the AA rated generic equivalent of Mikart, Inc's Hydrocodone Bitartrate and Acetaminophen Tablets. It is indicated for the relief of moderate to moderately severe pain. Hydrocodone Bitartrate and Acetaminophen Tablets USP had US sales of $89.6 million.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

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