Home Applications 210828 Application 210828
Type NDA
Sponsor UIHC PET IMAGING Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GALLIUM DOTATOC GA 68 GALLIUM DOTATOC GA-68 SOLUTION;INTRAVENOUS 0.5-4mCi/ML Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210828-001 GALLIUM GA 68 EDOTREOTIDE GALLIUM GA-68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS AP RLD, RS 2019-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N210828-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210828-001 ODE-383 2026-08-21 N210828-001 W 2026-08-21
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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210828-001 GALLIUM DOTATOC GA 68 0.5-4mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2019-08-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210828-001 GALLIUM GA 68 EDOTREOTIDE 0.5-4mCi/ML SOLUTION / INTRAVENOUS AP RLD, RS 2019-08-21 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 134 observed states.
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 24417-681 Ga-68-DOTATOC EDOTREOTIDE GALLIUM GA-68 UIHC NDA Current 24417-681 Ga-68-DOTATOC EDOTREOTIDE GALLIUM GA-68 UIHC NDA Current 24417-681 Ga-68-DOTATOC EDOTREOTIDE GALLIUM GA-68 UIHC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 74953 SUPPL 2023-07-31 74930 SUPPL 2023-07-31 69780 SUPPL 2021-12-27 69766 SUPPL 2021-12-27 60084 ORIG 2019-09-23 59782 ORIG 2019-09-16 59810 ORIG 2019-08-22