Home Applications 018511 Application 018511
Type NDA
Sponsor JUBILANT DRAXIMAGE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DRAXIMAGE DTPA TECHNETIUM TC-99M PENTETATE KIT INJECTABLE;INJECTION N/A Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N018511-001 DRAXIMAGE DTPA TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018511-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018511-001 DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018511-001 DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 e64feba35796…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DRAXIMAGE DTPA KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE Jubilant DraxImage Inc., dba Jubilant Radiopharma becdab53-f7a7-7280-6930-21f3a61b99e7 2023-05-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 018511 application number: NDA018511 ndc (product): 65174-288
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 65174-288 DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate Jubilant DraxImage Inc. NDA Current 65174-288 DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate Jubilant DraxImage Inc., dba Jubilant Radiopharma NDA Current 65174-288 DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate Jubilant DraxImage Inc., dba Jubilant Radiopharma NDA Current 65174-288 DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate Jubilant DraxImage Inc., dba Jubilant Radiopharma NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 74461 SUPPL 2023-06-08 74460 SUPPL 2023-06-08 72402 SUPPL 2022-10-17 72310 SUPPL 2022-10-12 51022 SUPPL 2018-01-10 50977 SUPPL 2017-12-29 50938 SUPPL 2017-12-28 33501 SUPPL 2011-09-29 937 SUPPL 2011-09-28 54162 SUPPL 1900-01-01 54161 SUPPL 1900-01-01