Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolixin Tablets, 1 mg, 2.5 mg, 5mg, and 10 mg, of Apothecon. Fluphenazine hydrochloride tablets, USP are indicated in the management of manifestations of psychotic disorders.
Alembic has a cumulative total of 210 ANDA approvals (182 final approvals and 28 tentative approvals) from USFDA.
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