Application 204677

Type: NDA
Sponsor: LIFE MOLECULAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEURACEQ	FLORBETABEN F-18	SOLUTION;INTRAVENOUS	30ML (1.4-135mCi/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204677-001	NEURACEQ	FLORBETABEN F-18	1.4-135mCi/ML	SOLUTION / INTRAVENOUS		RLD, RS	2014-03-19

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04
N204677-001	9308284	2032-07-14		Drug product	2025-07-31

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204677-001	NEURACEQ	1.4-135mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204677-001	NEURACEQ	30ML (1.4-135mCi/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2014-03-19	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204677-001	9308284	2032-07-14		Drug product	2025-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204677-001	9308284	2032-07-14		Drug product	2025-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204677-001	9308284	2032-07-14		Drug product	2025-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204677-001	7807135	2029-03-18	U-1497	Drug substance, Drug product	2014-04-04	`3a93d1ddd44b…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204677-001	NCE	2019-03-21	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N204677-001	NCE	2019-03-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204677-001	NCE	2019-03-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204677-001	NCE	2019-03-21	`ea99ee380514…`

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
Neuraceq	FLORBETABEN F 18	Lantheus Biosciences Ltd., a Lantheus company	b0915068-cfd4-4d72-b9f8-7e31fe83cd1e	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204677 application number: NDA204677 ndc (product): 54828-001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, SA	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, SA	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, SA	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, Ltd	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, Ltd	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, Ltd	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, SA	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Piramal Imaging, SA	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, SA	NDA	Current
54828-001	Neuraceq	florbetaben F 18	Life Molecular Imaging, SA	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82657	SUPPL	2025-06-24
82656	SUPPL	2025-06-24
82651	SUPPL	2025-06-24
82650	SUPPL	2025-06-24
76028	SUPPL	2023-11-02
76027	SUPPL	2023-11-02
71767	SUPPL	2022-08-10
71752	SUPPL	2022-08-09
61572	SUPPL	2020-01-14
61567	SUPPL	2020-01-14
48772	SUPPL	2017-06-19
48757	SUPPL	2017-06-19
45494	SUPPL	2016-10-06
45474	SUPPL	2016-10-04
45166	SUPPL	2016-08-25
45057	SUPPL	2016-08-25
43473	ORIG	2014-04-14
24479	ORIG	2014-04-14
19586	SUPPL	2014-04-08
32580	SUPPL	2014-04-04
32579	ORIG	2014-03-21
40411	ORIG	2014-03-20