Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204437
Company: UCSF RODIOPHARM
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
03/13/2014 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 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 204464 GLOBAL ISOTOPES LLC
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 203544 HOUSTON CYCLOTRON
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 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 203592 SOFIE
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 203912 SPECTRON MRC LLC
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204437 UCSF RODIOPHARM
SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 10-200mCi/ML INJECTABLE;INTRAVENOUS Prescription No AP 204497 UNIV UTAH CYCLOTRON

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English