The US Food and Drug Administration (FDA) has approved Boca Pharmacal's Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg / 325mg per 5ml abbreviated new drug application (ANDA) as a treatment for moderate to moderately severe pain.
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Boca’s Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg / 325mg per 5ml is the generic version of FSC Laboratories’ Hycet Oral Solution.
Boca CEO Robert Edwards said they have already filed a few ANDAs since January.
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