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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.

FLURAZEPAM HYDROCHLORIDE

ANDANot in Orange Book

FLURAZEPAM HYDROCHLORIDE | A071107 | HIKMA INTL PHARMS

API Supply Chain1 active DMF1 inactive

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

CAMBREX PROFARMACO MILANO SRLFLURAZEPAM HYDROCHLORIDE

DMF 35011979

SANOFI CHIMIEInactiveFLURAZEPAM HYDROCHLORIDE

DMF 68081987

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

Products (1)

#001 — 15MG

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CAPSULE;ORAL | Approved: Dec. 8, 1986

No patent or exclusivity listings for this strength.