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Aurobindo gets FDA approval for fluphenazine hydrochloride tablets

EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application fluphenazine hydrochloride tablets 1mg, 2.5mg, 5mg, and 10mg.

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application fluphenazine hydrochloride tablets 1mg, 2.5mg, 5mg, and 10mg. Aurobindo Pharma’s fluphenazine hydrochloride tablets are an AB-rated generic equivalent to the reference listed drug (RLD), Prolixin Tablets manufactured by Apothecon Inc.

Fluphenazine hydrochloride tablets are indicated for the management of manifestations of psychotic disorders.

Fluphenazine hydrochloride tablets has an estimated market size of US $24 million for the twelve months ending June 2023, as per IQVIA.

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