Application 017806

Type: NDA
Sponsor: LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THALLOUS CHLORIDE TL 201	THALLOUS CHLORIDE TL-201	INJECTABLE;INJECTION	1mCi/ML	Yes	Yes
002	THALLOUS CHLORIDE TL 201	THALLOUS CHLORIDE TL-201	INJECTABLE;INTRAVENOUS	2mCi/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N017806-001	THALLOUS CHLORIDE TL 201	THALLOUS CHLORIDE TL-201	1mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N017806-002	THALLOUS CHLORIDE TL 201	THALLOUS CHLORIDE TL-201	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	1998-10-09

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 · 84 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	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION		RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017806-001	THALLOUS CHLORIDE TL 201	1mCi/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017806-002	THALLOUS CHLORIDE TL 201	2mCi/ML	INJECTABLE / INTRAVENOUS		RLD	1998-10-09	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017806-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017806-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017806-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017806-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017806-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017806-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017806-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017806-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017806-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017806-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017806-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017806-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017806-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017806-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017806-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017806-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017806-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017806-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017806-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017806-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017806-001	AP	1	`cb3db0bc1861…`

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
THALLOUS CHLORIDE Tl 201	THALLOUS CHLORIDE, TL 201	Curium US LLC	0da81fc0-a137-46d3-9378-d8053a82e61a	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: THALLOUS CHLORIDE Tl 201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11994-427	Thallous Chloride Tl 201	THALLOUS CHLORIDE TL-201	Lantheus Medical Imaging, Inc.	NDA	Current
11994-427	Thallous Chloride Tl 201	THALLOUS CHLORIDE TL-201	Lantheus Medical Imaging, Inc.	NDA	Current
11994-427	Thallous Chloride Tl 201	THALLOUS CHLORIDE TL-201	Lantheus Medical Imaging, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
33348	SUPPL	2011-08-26
13902	SUPPL	2011-08-26