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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

FLUPHENAZINE HYDROCHLORIDE

ANDA

Tentative Approval

FLUPHENAZINE HYDROCHLORIDE | A089742 | LANNETT

API Supply Chain8 active DMFs2 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

FINE CHEMICALS CORP PTY LTDFLUPHENAZINE HYDROCHLORIDE

DMF 56481984

RAKS PHARMA PVT LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 333712018

MSN LIFE SCIENCES PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 337242019

ENALTEC LABS PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 338852019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFLUPHENAZINE HYDROCHLORIDE

DMF 339492019

ALEMBIC PHARMACEUTICALS LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 353662020

AURORE LIFE SCIENCES PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 356952021

CENTAUR PHARMACEUTICALS PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 363262021

ER SQUIBB AND SONS INCInactiveFLUPHENAZINE HYDROCHLORIDE

DMF 47031982

ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES)InactiveFLUPHENAZINE HYDROCHLORIDE

DMF 67151986

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 5MG

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TABLET;ORAL | Approved: 1988-08-25 00:00:00

No patent or exclusivity listings for this strength.