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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203603
Company: CARDINAL HEALTH 414

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription AP No No
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-500mCi/ML INJECTABLE;INTRAVENOUS Prescription AP No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/2015 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/27/2018 SUPPL-7 Labeling

Label is not available on this site.

FLUDEOXYGLUCOSE F18

INJECTABLE;INTRAVENOUS; 20-300mCi/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203778 3D IMAGING DRUG
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203710 BIOMEDCL RES FDN
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203837 BIOMEDCL RES FDN
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203816 BRIGHAM WOMENS
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203603 CARDINAL HEALTH 414
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204385 CHILDRENS HOSP MI
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204463 DECATUR
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204525 ISOLOGIC INNOVATIVE
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203920 JUBILANT DRAXIMAGE
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204333 MA GENERAL HOSP
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 208679 MEM SLOAN-KETTERING
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203904 METHODIST HOSP RES
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204472 MIPS CRF
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204512 NCM USA BRONX LLC
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204264 PHARMALOGIC
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203591 SOFIE
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203902 UCSF RODIOPHARM
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203990 UIHC PET IMAGING
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204531 UNIV MICHIGAN
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 209341 UNIV SOUTHERN CA
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203246 UNIV TX MD ANDERSON
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204498 UNIV UTAH CYCLOTRON
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203935 WUSM CYCLOTRON

INJECTABLE;INTRAVENOUS; 20-500mCi/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-500mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203603 CARDINAL HEALTH 414
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-500mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204546 PRECISION NUCLEAR
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-500mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203665 SOFIE
FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-500mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203709 WISCONSIN
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