Viewing data from:

FLUDEOXYGLUCOSE F18

ANDA

FLUDEOXYGLUCOSE F-18 | A203665 | SOFIE CO DBA SOFIE

1 strength0 unique patents0 unique exclusivities

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 19, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20-500mCi/ML

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Feb 14, 2013

No patent or exclusivity listings for this strength.