FDA.reportPublic FDA data

Application 018035

Type
NDA
Sponsor
JUBILANT DRAXIMAGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DRAXIMAGE MDP-10TECHNETIUM TC-99M MEDRONATEINJECTABLE;INJECTIONN/ANoNo
002DRAXIMAGE MDP-25TECHNETIUM TC-99M MEDRONATEINJECTABLE;INJECTIONN/AYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018035-001DRAXIMAGE MDP-10TECHNETIUM TC-99M MEDRONATEN/AINJECTABLE / INJECTIONApproved before 1982
N018035-002DRAXIMAGE MDP-25TECHNETIUM TC-99M MEDRONATEN/AINJECTABLE / INJECTIONRLD, RS2004-02-27

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-2784e616aacf4f…
2026-08-18 06:07:402026-07N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018035-001DRAXIMAGE MDP-10N/AINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018035-002DRAXIMAGE MDP-25N/AINJECTABLE / INJECTIONRLD, RS2004-02-2774a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Technetium Tc 99m MedronateTECHNETIUM TC 99M MEDRONATEJubilant DraxImage Inc., dba Jubilant Radiopharma3c91d0d8-6cc5-834c-bda0-aa83a873b9fb2025-03-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 018035
application number: NDA018035
ndc (product): 65174-660

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65174-660Technetium Tc 99m MedronateTechnetium Tc 99m MedronateJubilant DraxImage Inc., dba Jubilant RadiopharmaNDACurrent
65174-660Technetium Tc 99m MedronateTechnetium Tc 99m MedronateJubilant DraxImage IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82420SUPPL 2025-06-02
82329SUPPL 2025-05-27
11129SUPPL2011-09-29
13993SUPPL2011-09-28
13992SUPPL2010-10-26
33404SUPPL2010-10-25
805SUPPL2009-07-13
33403SUPPL2009-07-09
804SUPPL2004-03-02
20104ORIG2002-08-14
803SUPPL2002-07-03