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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.

TRIFLUOPERAZINE HCL

ANDA

Tentative Approval

TRIFLUOPERAZINE HYDROCHLORIDE | A089893 | QUAD PHARMS

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TRIFARMA SPATRIFLUOPERAZINE HYDROCHLORIDE

DMF 28531977

IRISH FINE CHEMICALS LTDInactiveTRIFLUOPERAZINE

DMF 35151979

SMITH KLINE AND FRENCH LABORATORIESInactiveTRIFLUOPERAZINE HYDROCHLORIDE

DMF 47881983

ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES)InactiveTRIFLUOPERAZINE

DMF 56991985

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

Products (1)

#001 — EQ 2MG BASE/ML

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.