FDA.reportPublic FDA data

Application 218845

Type
ANDA
Sponsor
METHODIST

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALLIUM GA 68 EDOTREOTIDEGALLIUM GA-68 EDOTREOTIDESOLUTION;INTRAVENOUS0.5-4mCi/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A218845-001GALLIUM GA 68 EDOTREOTIDEGALLIUM GA-68 EDOTREOTIDE0.5-4mCi/MLSOLUTION / INTRAVENOUSAP2025-10-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218845-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218845-001GALLIUM GA 68 EDOTREOTIDE0.5-4mCi/MLSOLUTION / INTRAVENOUSAP2025-10-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218845-001GALLIUM GA 68 EDOTREOTIDE0.5-4mCi/MLSOLUTION / INTRAVENOUSAP2025-10-1031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218845-001GALLIUM GA 68 EDOTREOTIDE0.5-4mCi/MLSOLUTION / INTRAVENOUSAP2025-10-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218845-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218845-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218845-001AP1a50c72e98297…