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Aurobindo receives FDA approval for oxycodone hydrochloride oral solution

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EAST WINDSOR, N.J. – Aurobindo has  received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application oxycodone hydrochloride oral solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL).  Aurobindo’s oxycodone hydrochloride oral solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL) are an AB-rated generic equivalent to the reference listed drug, Oxycodone Hydrochloride Oral Solution USP, 5 mg/5 mL (1 mg/mL) and 100 mg/5 mL (20 mg/mL), of Genus Lifesciences.

Oxycodone hydrochloride oral solution USP is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

 


ECRM_06-01-22


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