Home Applications 213227 Application 213227
Type NDA
Sponsor RADIOMEDIX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DETECTNET COPPER CU 64 DOTATATE INJECTABLE;INJECTION 148 MBq (4 mCi) (37 MBq (1mCi) per 1ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N213227-001 DETECTNET COPPER CU-64 DOTATATE 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213227-001 10159759 2032-08-23 U-2951 2020-10-01 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 N213227-001 12102696 2041-09-03 Drug product 2024-10-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213227-001 ODE-317 2027-09-03
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 2026-02-19 14:30 UTC 2026-02 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213227-001 DETECTNET 4mL (1mCi/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-03 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 116 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 10383961 2033-07-02 U-2951 2020-10-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213227-001 12102696 2041-09-03 Drug product 2024-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213227-001 11160888 2032-08-23 U-2951 2021-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213227-001 10159759 2032-08-23 U-2951 2020-10-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213227-001 10383961 2032-08-23 U-2951 2020-10-01 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 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 69945-064 Detectnet copper Cu 64 Dotatate CURIUM US LLC NDA Current 69945-064 Detectnet copper Cu 64 Dotatate CURIUM US LLC NDA Current 69945-064 Detectnet copper Cu 64 Dotatate CURIUM US LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 69779 SUPPL 2021-12-27 69767 SUPPL 2021-12-27 64636 ORIG 2020-09-22 64584 ORIG 2020-09-16 64491 ORIG 2020-09-04