Lupin earns FDA approval for Hycodan generic

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Lupin earns FDA approval for Hycodan generic

By Brian Berk - 02/17/2017

WASHINGTON — The U.S. Food and Drug Administration approved Mumbai, India-based Lupin’s ANDA for hydrocodone bitartrate and homatrophine methylbromide oral solution (Syrup), 5 mg/1.5 mg per 5 ml. It is a generic of Endo Pharmaceuticals’s Hycodan Oral Solution, 5 mg/1.5 mg per 5 ml.


Hycodan (hydrocodone bitartrate and homatropine methylbromide) is indicated for the symptomatic relief of cough in adults and children 6 years of age and older.


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