
Fluphenazine Tablets
Form: Oral Tablets
Strength: 1 mg, 2.5 mg, 5 mg, 10 mg
Reference Brands: Prolixin®(US); Modecate®(EU)
Category: Antipsychotropic Drugs
Fluphenazine tablets are FDA-approved in the United States for the treatment of schizophrenia and other chronic psychotic disorders. In the European Union, they are available in select countries via national authorizations. Regulatory requirements include GMP-compliant manufacturing, clinical safety data addressing extrapyramidal symptoms, and adherence to FDA and EMA psychiatric labeling standards. U.S. filings must comply with NDA or ANDA guidelines, including bioequivalence data. EU submissions may require bridging studies and updated pharmacovigilance plans. To explore dossier-ready Fluphenazine tablets, alternate forms, and verified suppliers, visit Pharmatradz.com — your global B2B platform for pharmaceutical sourcing.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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