Home Applications 018107 Application 018107
Type NDA
Sponsor CARDINAL HEALTH 414 Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MDP-BRACCO TECHNETIUM TC-99M MEDRONATE KIT INJECTABLE;INJECTION N/A 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 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018107-001 AP
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018107-001 MDP-BRACCO N/A INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018107-001 MDP-BRACCO N/A INJECTABLE / INJECTION Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018107-001 MDP-BRACCO N/A INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018107-001 MDP-BRACCO N/A INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018107-001 MDP-BRACCO N/A INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018107-001 MDP-BRACCO N/A INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018107-001 MDP-BRACCO N/A INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018107-001 MDP-BRACCO N/A INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018107-001 TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE / INJECTION AP Approved before 1982 cb3db0bc1861…
Observed Orange Book normalized TE 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65857-505 Kit for the Preparation of Technetium Tc 99m Medronate technetium tc 99m medronate Cardinal Health 414, LLC NDA Current 65857-505 Kit for the Preparation of Technetium Tc 99m Medronate technetium tc 99m medronate Cardinal Health 414, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82439 SUPPL 2025-06-03 82330 SUPPL 2025-05-27 65221 SUPPL 2020-11-16 843 SUPPL 2008-11-28