Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203777
Company: 3D IMAGING DRUG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/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
10/19/2015 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
06/24/2020 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

SODIUM FLUORIDE F-18

INJECTABLE;INTRAVENOUS; 10-200mCi/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203777 3D IMAGING DRUG
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204351 BIOMEDCL RES FDN
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203780 CARDINAL HEALTH 414
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204464 DECATUR
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204541 ESSENTIAL ISOTOPES
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204530 HOT SHOTS NM LLC
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203968 JUBILANT DRAXIMAGE
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203936 KREITCHMAN PET CTR
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204440 MIDWEST MEDCL
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204517 MIPS CRF
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204513 NCM USA BRONX LLC
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203912 NUKEMED
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203890 PETNET
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204542 PRECISION NUCLEAR
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204315 SHERTECH LABS LLC
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203544 SOFIE
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203592 SOFIE
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204497 UNIV UTAH CYCLOTRON

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