Application 018035

Type: NDA
Sponsor: JUBILANT DRAXIMAGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DRAXIMAGE MDP-10	TECHNETIUM TC-99M MEDRONATE	INJECTABLE;INJECTION	N/A	No	No
002	DRAXIMAGE MDP-25	TECHNETIUM TC-99M MEDRONATE	INJECTABLE;INJECTION	N/A	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018035-001	DRAXIMAGE MDP-10	TECHNETIUM TC-99M MEDRONATE	N/A	INJECTABLE / INJECTION		Approved before 1982
N018035-002	DRAXIMAGE MDP-25	TECHNETIUM TC-99M MEDRONATE	N/A	INJECTABLE / INJECTION		RLD, RS	2004-02-27

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018035-001	DRAXIMAGE MDP-10	N/A	INJECTABLE / INJECTION	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018035-002	DRAXIMAGE MDP-25	N/A	INJECTABLE / INJECTION	RLD, RS	2004-02-27	`3a93d1ddd44b…`

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
Technetium Tc 99m Medronate	TECHNETIUM TC 99M MEDRONATE	Jubilant DraxImage Inc., dba Jubilant Radiopharma	3c91d0d8-6cc5-834c-bda0-aa83a873b9fb	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018035 application number: NDA018035 ndc (product): 65174-660

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65174-660	Technetium Tc 99m Medronate	Technetium Tc 99m Medronate	Jubilant DraxImage Inc., dba Jubilant Radiopharma	NDA	Current
65174-660	Technetium Tc 99m Medronate	Technetium Tc 99m Medronate	Jubilant DraxImage Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82420	SUPPL	2025-06-02
82329	SUPPL	2025-05-27
11129	SUPPL	2011-09-29
13993	SUPPL	2011-09-28
13992	SUPPL	2010-10-26
33404	SUPPL	2010-10-25
805	SUPPL	2009-07-13
33403	SUPPL	2009-07-09
804	SUPPL	2004-03-02
20104	ORIG	2002-08-14
803	SUPPL	2002-07-03