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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

DROPERIDOL

ANDANot in Orange Book

DROPERIDOL | A071941 | QUAD PHARMS

API Supply Chain2 active DMFs4 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

JANSSEN PHARMACEUTICA NVInactiveDROPERIDOL,CODE#R4749,MNFG IN BELGIUM AND PUERTO RICO FACILITIES

DMF 48901983

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.