Home Applications 208547 Application 208547
Type NDA
Sponsor AAA USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NETSPOT GALLIUM DOTATATE GA-68 POWDER;INTRAVENOUS 2.1-5.5mCi/ML Yes Yes
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 N208547-001 NETSPOT GALLIUM DOTATATE GA-68 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208547-001 9375498 2032-08-10 Drug product 2018-07-09
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 1 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 2026-09-14 22:38:34 2026-08 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 f41ea6bd6efb…
Observed Orange Book exclusivity history# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NETSPOT 68GA-DOTATATE Advanced Accelerator Applications USA, Inc b2b3be70-17d8-4093-896c-f1c54a2cf242 2026-07-06 Warnings, Adverse reactions Exact identifier application applno (NDA): 208547 application number: NDA208547 ndc (product): 69488-001
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69488-001 NETSPOT 68Ga-DOTATATE Advanced Accelerator Applications USA, Inc NDA Current 69488-001 NETSPOT 68Ga-DOTATATE Advanced Accelerator Applications USA, Inc NDA Current 69488-001 NETSPOT 68Ga-DOTATATE Advanced Accelerator Applications USA, Inc NDA Current 69488-001 NETSPOT 68Ga-DOTATATE Advanced Accelerator Applications USA, Inc NDA Current 69488-001 NETSPOT 68Ga-DOTATATE Advanced Accelerator Applications USA, Inc NDA Current 69488-001 NETSPOT 68Ga-DOTATATE Advanced Accelerator Applications USA, Inc NDA Current