Related links
K212808.pdf - accessdata.fda.gov
Jun 14, 2022 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations
Learn more
NDA 21-768: FDG F 18 Injection Page 4 - accessdata.fda.gov
Fludeoxyglucose F 18 Injection is provided as a ready to use isotonic, sterile, pyrogen free, clear, colorless citrate buffered solution.
Learn more
Office of Clinical Pharmacology Review
Sep 1, 2016 Acceptable to FDA. 2. Sponsor obtained PHT concentration data after IV Dilantin administration to children from Ogutu et al. (2003), study.
Learn more