Application 017243

Type: NDA
Sponsor: CURIUM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ULTRA-TECHNEKOW FM	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	SOLUTION;INTRAVENOUS	0.25-3 CI/GENERATOR	No	No
003	ULTRA-TECHNEKOW FM	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	SOLUTION;INTRAVENOUS	1-19 CI/GENERATOR	Yes	Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017243-002	ULTRA-TECHNEKOW V4	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS		Approved before 1982
N017243-003	ULTRA-TECHNEKOW V4	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS		RLD, RS	2014-02-18

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017243-002	ULTRA-TECHNEKOW FM	0.25-3 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017243-003	ULTRA-TECHNEKOW FM	1-19 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-18	`f41ea6bd6efb…`

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
Ultra-Technekow V4	TECHNETIUM TC-99M	Curium US LLC	98947d99-5be5-461e-ad36-7425d3646389	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017243 application number: NDA017243 ndc (product): 69945-140 ndc (product): 69945-030 ndc (product): 69945-060 ndc (product): 69945-010 ndc (product): 69945-075 ndc (product): 69945-051 ndc (product): 69945-160 ndc (product): 69945-190 ndc (product): 69945-025 ndc (product): 69945-110 ndc (product): 69945-020 ndc (product): 69945-035 ndc (product): 69945-015

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 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69945-010	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-010	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-010	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-015	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-015	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-015	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-020	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-020	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-020	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-025	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-025	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-025	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-030	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-030	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-030	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-035	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-035	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-035	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-051	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-051	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-051	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-060	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-060	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-060	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-075	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-075	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-075	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-110	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-110	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-110	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-140	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-140	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-140	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-160	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-160	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-160	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-190	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-190	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-190	Ultra-Technekow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-883	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-884	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-884	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-885	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-885	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-886	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-886	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-887	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-887	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-888	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-888	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-889	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-889	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-890	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-890	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-891	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-891	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-892	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-892	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-893	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-893	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-894	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-894	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current
69945-895	Ultra-TechneKow	Technetium Tc-99m	MALLINCKRODT NUCLEAR MEDICINE LLC	NDA	Current
69945-895	Ultra-TechneKow	Technetium Tc-99m	Curium US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33239	SUPPL	2015-05-06
560	SUPPL	2015-05-05
33237	SUPPL	2014-02-19
13103	SUPPL	2014-02-19
33238	SUPPL	2014-01-13
559	SUPPL	2013-12-24
13102	SUPPL	2006-04-05
10973	SUPPL	2004-10-22
558	SUPPL	2004-10-22
557	SUPPL	2004-06-29