Alembic Pharmaceuticals has achieved final FDA approval for its Abbreviated New Drug Application (ANDA) Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.
The authorised ANDA is therapeutically similar to Apothecon’s reference listed drug product (RLD), Prolixin Tablets in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg. Fluphenazine hydrochloride tablets, USP are recommended for the treatment of psychotic illnesses.
Alembic has 210 ANDA approvals from the USFDA, including 182 final approvals and 28 tentative clearances.
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