Application 019785

Type: NDA
Sponsor: LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIOLITE	TECHNETIUM TC-99M SESTAMIBI KIT	INJECTABLE;INJECTION	N/A	Yes	Yes
003	MIRALUMA	TECHNETIUM TC-99M SESTAMIBI KIT	INJECTABLE;INJECTION	N/A	No	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
N019785-001	CARDIOLITE	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21
N019785-003	MIRALUMA	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE / INJECTION			1997-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019785-001	AP

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	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019785-001	CARDIOLITE	N/A	INJECTABLE / INJECTION	AP	RLD, RS	1990-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019785-003	MIRALUMA	N/A	INJECTABLE / INJECTION			1997-05-23	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019785-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019785-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019785-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019785-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019785-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019785-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019785-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019785-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019785-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019785-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019785-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019785-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019785-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019785-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019785-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019785-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019785-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019785-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019785-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019785-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019785-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019785-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019785-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019785-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019785-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019785-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019785-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019785-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019785-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019785-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019785-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019785-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019785-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019785-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019785-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019785-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019785-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019785-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019785-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019785-001	AP	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	49662def-2fb9-47b2-8467-ca56f6006167	2022-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019785 application number: NDA019785 ndc (product): 11994-001
Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	8c03a854-185a-45d7-883f-9f87e4750181	2022-11-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019785 application number: NDA019785 ndc (product): 11994-003

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
11994-001	Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-001	Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-001	Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-003	Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-003	Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current
11994-003	Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	Lantheus Medical Imaging, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61160	SUPPL	2019-12-05
61177	SUPPL	2019-12-04
44633	SUPPL	2008-07-17
19216	SUPPL	2008-06-18
11716	SUPPL	2008-06-18
52889	SUPPL	2008-01-11
52888	SUPPL	2008-01-11
52356	SUPPL	2008-01-11
64766	SUPPL	1900-01-01