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FLUDEOXYGLUCOSE F18

ANDA

FLUDEOXYGLUCOSE F-18 | A079086 | PETNET SOLUTIONS INC

1 strength0 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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 2, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20-200mCi/ML

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Feb 25, 2011

No patent or exclusivity listings for this strength.