Home Applications 208700 Application 208700
Type NDA
Sponsor AAA USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LUTATHERA LUTETIUM DOTATATE LU-177 SOLUTION;INTRAVENOUS 10mCi/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 N208700-001 LUTATHERA LUTETIUM LU 177 DOTATATE 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208700-001 10596276 2038-07-25 Drug product 2020-04-13 N208700-001 10596278 2038-07-25 Drug product 2020-04-13 N208700-001 11904027 2038-07-25 Drug product 2024-03-15 N208700-001 12144873 2038-07-25 U-4036 2024-11-19 N208700-001 12151003 2038-07-25 U-4036 Drug product 2024-11-26 N208700-001 12161732 2038-07-25 U-4036 Drug product 2024-12-10 N208700-001 12168063 2038-07-25 U-4036 Drug product 2024-12-17 N208700-001 12415003 2038-07-25 U-4036 2025-09-17 N208700-001 12491272 2038-07-25 U-4036 2025-12-16 N208700-001 10596276*PED 2039-01-25 Pediatric extension N208700-001 10596278*PED 2039-01-25 Pediatric extension N208700-001 11904027*PED 2039-01-25 Pediatric extension N208700-001 12144873*PED 2039-01-25 Pediatric extension N208700-001 12151003*PED 2039-01-25 Pediatric extension N208700-001 12161732*PED 2039-01-25 Pediatric extension N208700-001 12168063*PED 2039-01-25 Pediatric extension N208700-001 12415003*PED 2039-01-25 Pediatric extension N208700-001 12491272*PED 2039-01-25 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208700-001 LUTATHERA 10mCi/ML SOLUTION / INTRAVENOUS RLD, RS 2018-01-26 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 6 · 235 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 N208700-001 10596276 2038-07-25 Drug product 2020-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 10596278 2038-07-25 Drug product 2020-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 11904027 2038-07-25 Drug product 2024-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12144873 2038-07-25 U-4036 2024-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12151003 2038-07-25 U-4036 Drug product 2024-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12161732 2038-07-25 U-4036 Drug product 2024-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12168063 2038-07-25 U-4036 Drug product 2024-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12415003 2038-07-25 U-4036 2025-09-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12491272 2038-07-25 U-4036 2025-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 10596276*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 10596278*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 11904027*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12144873*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12151003*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12161732*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12168063*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12415003*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208700-001 12491272*PED 2039-01-25 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208700-001 10596276 2038-07-25 Drug product 2020-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 10596278 2038-07-25 Drug product 2020-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 11904027 2038-07-25 Drug product 2024-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12144873 2038-07-25 U-4036 2024-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12151003 2038-07-25 U-4036 Drug product 2024-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12161732 2038-07-25 U-4036 Drug product 2024-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12168063 2038-07-25 U-4036 Drug product 2024-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12415003 2038-07-25 U-4036 2025-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12491272 2038-07-25 U-4036 2025-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 10596276*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 10596278*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 11904027*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12144873*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12151003*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12161732*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12168063*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12415003*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208700-001 12491272*PED 2039-01-25 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208700-001 10596276 2038-07-25 Drug product 2020-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208700-001 10596278 2038-07-25 Drug product 2020-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208700-001 11904027 2038-07-25 Drug product 2024-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208700-001 12144873 2038-07-25 U-4036 2024-11-19 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 138 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lutathera LUTETIUM LU 177 DOTATATE Advanced Accelerator Applications USA, Inc 72d1a024-00b7-418a-b36e-b2cb48f2ab55 2026-01-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 208700 application number: NDA208700 ndc (product): 69488-003
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69488-003 Lutathera Lutetium Lu 177 dotatate Advanced Accelerator Applications USA, Inc NDA Current 69488-003 Lutathera Lutetium Lu 177 dotatate Advanced Accelerator Applications USA, Inc NDA Current 69488-003 Lutathera Lutetium Lu 177 dotatate Advanced Accelerator Applications USA, Inc NDA Current 69488-003 Lutathera Lutetium Lu 177 dotatate Advanced Accelerator Applications USA, Inc NDA Current