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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.

PROCAINAMIDE HYDROCHLORIDE

ANDANot in Orange Book

PROCAINAMIDE HYDROCHLORIDE | A089371 | IDT AUSTRALIA LTD

API Supply Chain4 active DMFs1 inactive

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

W R GRACE AND CO -CONNPROCAINAMIDE HYDROCHLORIDE

DMF 49111983

CHENG FONG CHEMICAL CO LTDPROCAINAMIDE HYDROCHLORIDE USP

DMF 254612011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPROCAINAMIDE HYDROCHLORIDE USP

DMF 332162018

GLAND PHARMA LTDPROCAINAMIDE HYDROCHLORIDE

DMF 364022021

GANES CHEMICALS INC PENNSVILLE DIVInactivePROCAINAMIDE HYDROCHLORIDE

DMF 21331973

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

Products (1)

#001 — 750MG

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TABLET, EXTENDED RELEASE;ORAL | Approved: Aug. 14, 1987

No patent or exclusivity listings for this strength.