FDA.reportPublic FDA data

Application 203247

Type
ANDA
Sponsor
UNIV TX MD ANDERSON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM FLUORIDE F-18SODIUM FLUORIDE F-18INJECTABLE;INTRAVENOUS10-200mCi/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203247-001SODIUM FLUORIDE F-18SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2013-12-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A203247-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2013-12-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203247-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2013-12-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203247-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2013-12-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203247-001SODIUM FLUORIDE F-1810-200mCi/MLINJECTABLE / INTRAVENOUS2013-12-23a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Fluoride F 18SODIUM FLUORIDE F-18Biomedical Research Foundation of Northwest Louisiana4c45fe05-e3b7-4383-966c-4e218ff6f94a2026-06-10Warnings, Adverse reactionsName fallback
generic name: SODIUM FLUORIDE F-18
Sodium Fluoride F 18SODIUM FLUORIDE F-18Kreitchman PET Centerdf1389d2-1b9b-4327-856e-5ba38118d3892026-01-27Adverse reactionsName fallback
generic name: SODIUM FLUORIDE F-18
Sodium Fluoride F 18SODIUM FLUORIDE F-183D Imaging Drug Design and Development LLCeeaf4f42-e3c6-4e0a-aa79-89722511eaea2026-01-07Warnings, Adverse reactionsName fallback
generic name: SODIUM FLUORIDE F-18
Sodium Fluoride F 18SODIUM FLUORIDE F-18Precision Nuclear LLCd834721b-b624-4b27-9009-95e09827122e2025-12-21Warnings, Adverse reactionsName fallback
generic name: SODIUM FLUORIDE F-18
Sodium Fluoride F 18SODIUM FLUORIDE F-18SOFIE Co.2bbd8f48-fdf9-45cb-8305-124a03f7a52c2025-04-03Warnings, Adverse reactionsName fallback
generic name: SODIUM FLUORIDE F-18
Sodium Fluoride F 18SODIUM FLUORIDE F-18BAMF Health Inc.ef58c3cd-a922-c5fc-e053-2a95a90a9d742023-12-29Warnings, Adverse reactionsName fallback
generic name: SODIUM FLUORIDE F-18

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.