Application 208054

Type: NDA
Sponsor: BLUE EARTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AXUMIN	FLUCICLOVINE F-18	SOLUTION;INTRAVENOUS	9-221mCi/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N208054-001	AXUMIN	FLUCICLOVINE F-18	9-221mCi/ML	SOLUTION / INTRAVENOUS		RLD, RS	2016-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208054-001	10010632	2026-11-28		Drug product	2018-07-27
N208054-001	10953112	2026-11-28	U-1879		2021-04-20
N208054-001	9387266	2026-11-28	U-1879		2016-07-28
N208054-001	10124079	2035-12-30	U-2450		2018-12-12
N208054-001	10716868	2035-12-30	U-2450		2020-07-22
N208054-001	10933147	2035-12-30	U-2450		2021-03-09
N208054-001	10967077	2035-12-30	U-2450		2021-04-20
N208054-001	11980674	2042-04-23	U-2450		2024-06-10

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208054-001	AXUMIN	9-221mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2016-05-27	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 296 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10010632	2026-11-28		Drug product	2018-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10953112	2026-11-28	U-1879		2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	9387266	2026-11-28	U-1879		2016-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10124079	2035-12-30	U-2450		2018-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10716868	2035-12-30	U-2450		2020-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10933147	2035-12-30	U-2450		2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	10967077	2035-12-30	U-2450		2021-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208054-001	11980674	2042-04-23	U-2450		2024-06-10	`6a471c1ec25d…`

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	N208054-001	NCE	2021-05-27	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208054-001	NCE	2021-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208054-001	NCE	2021-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208054-001	NCE	2021-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208054-001	NCE	2021-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208054-001	NCE	2021-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208054-001	NCE	2021-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208054-001	NCE	2021-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208054-001	NCE	2021-05-27	`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
Axumin	FLUCICLOVINE F-18	Blue Earth Diagnostics	389a502e-a7d5-43dd-b6bf-f022ff23f3b9	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208054 application number: NDA208054 ndc (product): 69932-001

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69932-001	Axumin	Fluciclovine F-18	Blue Earth Diagnostics	NDA	Current
69932-001	Axumin	Fluciclovine F-18	Blue Earth Diagnostics	NDA	Current
69932-001	Axumin	Fluciclovine F-18	Blue Earth Diagnostics	NDA	Current
69932-001	Axumin	Fluciclovine F-18	Blue Earth Diagnostics	NDA	Current
69932-001	Axumin	Fluciclovine F-18	Blue Earth Diagnostics	NDA	Current
69932-001	Axumin	Fluciclovine F-18	Blue Earth Diagnostics	NDA	Current
69932-001	Axumin	Fluciclovine F-18	Blue Earth Diagnostics	NDA	Current
69932-001	Axumin	Fluciclovine F-18	Blue Earth Diagnostics	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67582	SUPPL	2021-05-24
67579	SUPPL	2021-05-24
43543	ORIG	2016-06-21
24532	ORIG	2016-06-21
40615	ORIG	2016-05-27
32882	ORIG	2016-05-27