Home Applications 212642 Application 212642
Type NDA
Sponsor UNIV CALIFORNIA LOS ANGELES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GALLIUM Ga 68 PSMA-11 PSMA-11 Ga 68 INJECTABLE;INJECTION 18.5MBQ/ML to 185MBQ/ML (0.5MCI/ML to 5MCI/ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N212642-001 GALLIUM GA 68 GOZETOTIDE GALLIUM GA-68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2020-12-01
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5MCI/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5MCI/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212642-001 GALLIUM GA 68 PSMA-11 30ML (0.5-5MCI/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/mL SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212642-001 GALLIUM GA 68 GOZETOTIDE 30ML (0.5-5mCi/mL) SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212642-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2020-12-01 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 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.
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 76394-2642 Gallium Ga-68 PSMA-11 GALLIUM GA-68 GOZETOTIDE UCLA Biomedical Cyclotron NDA Current 76394-2642 Gallium Ga-68 PSMA-11 GALLIUM GA-68 GOZETOTIDE UCLA Biomedical Cyclotron NDA Current 76394-2642 Gallium Ga-68 PSMA-11 GALLIUM GA-68 GOZETOTIDE UCLA Biomedical Cyclotron NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71355 SUPPL 2022-06-21 71346 SUPPL 2022-06-17 69351 SUPPL 2021-11-18 69348 SUPPL 2021-11-18 65603 ORIG 2020-12-16 65486 ORIG 2020-12-02 65482 ORIG 2020-12-02