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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.

BRETYLIUM TOSYLATE

ANDANot in Orange Book

BRETYLIUM TOSYLATE | A071181 | QUAD PHARMS

API Supply Chain1 active DMF2 inactive

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

TOPCHEM PHARMACEUTICALS LTDBRETYLIUM TOSYLATE

DMF 259372012

GANES CHEMICALS INC PENNSVILLE DIVInactiveBRETYLIUM TOSYLATE

DMF 27291976

DELMAR CHEMICALS INCInactiveBRETYLIUM TOSYLATE, BULK FORM

DMF 33611978

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

Products (1)

#001 — 50MG/ML

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.