FDA.reportPublic FDA data

Application 212643

Type
NDA
Sponsor
UNIV CALIFORNIA LOS ANGELES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALLIUM GA 68 PSMA-11PSMA-11 Ga 68INJECTABLE;INJECTION18.5MBQ/ML to 185MBQ/ML(0.5MCI/ML to 5MCI/ML)YesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N212643-001GALLIUM GA 68 GOZETOTIDEGALLIUM GA-68 GOZETOTIDE0.5-5mCi/MLSOLUTION / INTRAVENOUSAPRLD, RS2020-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N212643-001AP

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
2026-09-14 22:38:342026-08N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/MLSOLUTION / INTRAVENOUSAPRLD, RS2020-12-0184e616aacf4f…
2026-08-18 06:07:402026-07N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/MLSOLUTION / INTRAVENOUSAPRLD, RS2020-12-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212643-001GALLIUM GA 68 PSMA-1120ML (0.5-5mCi/mL)SOLUTION / INTRAVENOUSRLD, RS2020-12-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212643-001GALLIUM GA 68 PSMA-1120ML (0.5-5mCi/mL)SOLUTION / INTRAVENOUSRLD, RS2020-12-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212643-001GALLIUM GA 68 PSMA-1120ML (0.5-5mCi/mL)SOLUTION / INTRAVENOUSRLD, RS2020-12-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N212643-001GALLIUM GA 68 PSMA-1120ML (0.5-5mCi/mL)SOLUTION / INTRAVENOUSRLD, RS2020-12-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212643-001GALLIUM GA 68 PSMA-1120ML (0.5-5MCI/ML)SOLUTION / INTRAVENOUSRLD, RS2020-12-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212643-001GALLIUM GA 68 PSMA-1120ML (0.5-5MCI/ML)SOLUTION / INTRAVENOUSRLD, RS2020-12-0187673890dc5c…
2021-03-12 10:30 UTC2021-03N212643-001GALLIUM GA 68 PSMA-1120ML (0.5-5MCI/ML)SOLUTION / INTRAVENOUSRLD, RS2020-12-015aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-013f0d92c62455…
2023-05-13 08:27 UTC2023-05N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01053a50430f4f…
2023-01-26 05:58 UTC2023-01N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/mLSOLUTION / INTRAVENOUSRLD, RS2020-12-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N212643-001GALLIUM GA 68 GOZETOTIDE20ML (0.5-5mCi/mL)SOLUTION / INTRAVENOUSRLD, RS2020-12-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212643-001GALLIUM GA 68 GOZETOTIDE0.5-5mCi/MLSOLUTION / INTRAVENOUSAPRLD, RS2020-12-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N212643-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N212643-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212643-001AP1a50c72e98297…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212643-001NCE2025-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212643-001W2025-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N212643-001NCE2025-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212643-001W2025-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212643-001NCE2025-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212643-001W2025-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212643-001NCE2025-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212643-001W2025-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212643-001NCE2025-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212643-001W2025-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212643-001NCE2025-12-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212643-001W2025-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212643-001NCE2025-12-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212643-001W2025-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212643-001NCE2025-12-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212643-001W2025-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212643-001NCE2025-12-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N212643-001W2025-12-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212643-001NCE2025-12-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212643-001W2025-12-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212643-001NCE2025-12-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212643-001W2025-12-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212643-001NCE2025-12-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212643-001W2025-12-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212643-001NCE2025-12-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05N212643-001W2025-12-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212643-001NCE2025-12-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212643-001W2025-12-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212643-001NCE2025-12-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N212643-001W2025-12-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212643-001NCE2025-12-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N212643-001W2025-12-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N212643-001NCE2025-12-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N212643-001W2025-12-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212643-001NCE2025-12-01782e0a99824c…
2021-12-28 21:50 UTC2021-12N212643-001W2025-12-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212643-001NCE2025-12-0187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212643-001W2025-12-0187673890dc5c…
2021-03-12 10:30 UTC2021-03N212643-001NCE2025-12-015aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N212643-001W2025-12-015aa47cf7b7d7…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCSF Radiopharmaceutical Facilityb6253a7b-0f73-36be-e053-2a95a90a90152025-11-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 212643
application number: NDA212643
ndc (product): 24275-0525

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24275-0525Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCSF Radiopharmaceutical FacilityNDACurrent
24275-0525Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCSF Radiopharmaceutical FacilityNDACurrent
24275-0525Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCSF Radiopharmaceutical FacilityNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71354SUPPL2022-06-21
69350SUPPL2021-11-18
69349SUPPL2021-11-18
65605ORIG2020-12-17
65485ORIG2020-12-02
65483ORIG2020-12-02