Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204517
Company: MIPS CRF
Company: MIPS CRF
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 |
---|---|---|---|---|---|---|---|
07/21/2015 | ORIG-1 | Approval |
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 | 216126 | BAMF |
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 | 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 | 203592 | SOFIE |
SODIUM FLUORIDE F-18 | SODIUM FLUORIDE F-18 | 10-200mCi/ML | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204497 | UNIV UTAH CYCLOTRON |