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FLUDEOXYGLUCOSE F18

ANDA

FLUDEOXYGLUCOSE F-18 | A203603 | CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FLUDEOXYGLUCOSE F18(TE code: AP)

API Supply Chain0 active DMFs2 inactive

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

INSTITUTE CLINICAL PETInactiveFLUDEOXYGLUCOSE F-18 INJECTION

DMF 90571991

GENERAL ELECTRIC MEDICAL SYSTEMSInactiveFLUDEOXYGLUCOSE F-18 INJECTION

DMF 132681998

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

Products (2)

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#001 — 20-300mCi/ML

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Nov 13, 2015

No patent or exclusivity listings for this strength.

#002 — 20-500mCi/ML

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Sep 27, 2018