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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204264
Company: SHERTECH LABS LLC

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/2014 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
12/27/2017 SUPPL-1 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 SHERTECH LABS LLC
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
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