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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.

DROPERIDOL

ANDA

Tentative Approval

DROPERIDOL | A071942 | QUAD PHARMS

API Supply Chain2 active DMFs3 inactive

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

JOINT STOCK CO GRINDEKSDROPERIDOL USP

DMF 229752009

MEHTA API PVT LTDDROPERIDOL USP

DMF 421102025

NV ORGANONInactiveDROPERIDOL

DMF 57731985

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveDROPERIDOL

DMF 75391988

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveDROPERIDOL USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE

DMF 138971998

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

Products (1)

#001 — 2.5MG/ML

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.