Application 017771

Type: NDA
Sponsor: LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TECHNELITE	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	SOLUTION;INTRAVENOUS	0.0083-2.7 CI/GENERATOR	No	No
002	TECHNELITE	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	SOLUTION;INTRAVENOUS	1-20 CI/GENERATOR	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
N017771-001	TECHNELITE	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS		Approved before 1982
N017771-002	TECHNELITE	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS		RLD, RS	2014-02-12

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	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017771-001	TECHNELITE	0.0083-2.7 CI/GENERATOR	SOLUTION / INTRAVENOUS	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017771-002	TECHNELITE	1-20 CI/GENERATOR	SOLUTION / INTRAVENOUS	RLD, RS	2014-02-12	`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
TechneLite	TECHNETIUM TC99M GENERATOR	Lantheus Medical Imaging, Inc.	3ae14c6b-3daf-4dd1-bbdb-e990fe8100e4	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017771 application number: NDA017771 ndc (product): 11994-091 ndc (product): 11994-090

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11994-090	TechneLite	Technetium Tc99m Generator	Lantheus Medical Imaging, Inc.	NDA	Current
11994-090	TechneLite	Technetium Tc99m Generator	Lantheus Medical Imaging, Inc.	NDA	Current
11994-090	TechneLite	Technetium Tc99m Generator	Lantheus Medical Imaging, Inc.	NDA	Current
11994-091	TechneLite	Technetium Tc99m Generator	Lantheus Medical Imaging, Inc.	NDA	Current
11994-091	TechneLite	Technetium Tc99m Generator	Lantheus Medical Imaging, Inc.	NDA	Current
11994-091	TechneLite	Technetium Tc99m Generator	Lantheus Medical Imaging, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73276	SUPPL	2023-01-23
73266	SUPPL	2023-01-23
13899	SUPPL	2014-02-13
33343	SUPPL	2014-02-12