Application 215168

Type: NDA
Sponsor: GE HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLYRCADO	FLURPIRIDAZ F-18	SOLUTION;INTRAVENOUS	5-55mCi/ML	Yes	Yes

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

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
N215168-001	FLYRCADO	FLURPIRIDAZ F-18	5-55mCi/ML	SOLUTION / INTRAVENOUS		RLD, RS	2024-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22
N215168-001	7344702	2026-05-26		Drug substance	2024-10-22
N215168-001	8226929	2028-06-21	U-4011		2024-10-22
N215168-001	9603951	2031-05-02	U-4011		2024-10-22
N215168-001	8936777	2031-06-30	U-4011		2024-10-22
N215168-001	9687571	2032-11-01	U-4011	Drug product	2024-10-22
N215168-001	12527884	2042-05-13	U-4406	Drug product	2026-02-11

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215168-001	NCE	2029-09-27

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215168-001	FLYRCADO	5-55mCi/ML	SOLUTION / INTRAVENOUS	RLD, RS	2024-09-27	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215168-001	7344702	2026-05-26		Drug substance	2024-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215168-001	8226929	2028-06-21	U-4011		2024-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215168-001	9603951	2031-05-02	U-4011		2024-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215168-001	8936777	2031-06-30	U-4011		2024-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215168-001	9687571	2032-11-01	U-4011	Drug product	2024-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215168-001	12527884	2042-05-13	U-4406	Drug product	2026-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215168-001	7344702	2026-05-26		Drug substance	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215168-001	8226929	2028-06-21	U-4011		2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215168-001	9603951	2031-05-02	U-4011		2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215168-001	8936777	2031-06-30	U-4011		2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215168-001	9687571	2032-11-01	U-4011	Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215168-001	12527884	2042-05-13	U-4406	Drug product	2026-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215168-001	7344702	2026-05-26		Drug substance	2024-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215168-001	8226929	2028-06-21	U-4011		2024-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215168-001	9603951	2031-05-02	U-4011		2024-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215168-001	8936777	2031-06-30	U-4011		2024-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215168-001	9687571	2032-11-01	U-4011	Drug product	2024-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215168-001	7344702	2026-05-26		Drug substance	2024-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215168-001	8226929	2028-06-21	U-4011		2024-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215168-001	9603951	2031-05-02	U-4011		2024-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215168-001	8936777	2031-06-30	U-4011		2024-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215168-001	9687571	2032-11-01	U-4011	Drug product	2024-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215168-001	7344702	2026-05-26		Drug substance	2024-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215168-001	8226929	2028-06-21	U-4011		2024-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215168-001	9603951	2031-05-02	U-4011		2024-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215168-001	8936777	2031-06-30	U-4011		2024-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215168-001	9687571	2032-11-01	U-4011	Drug product	2024-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215168-001	7344702	2026-05-26		Drug substance	2024-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215168-001	8226929	2028-06-21	U-4011		2024-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215168-001	9603951	2031-05-02	U-4011		2024-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215168-001	8936777	2031-06-30	U-4011		2024-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215168-001	9687571	2032-11-01	U-4011	Drug product	2024-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215168-001	9161997	2026-02-04	U-4011	Drug substance, Drug product	2024-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215168-001	7344702	2026-05-26		Drug substance	2024-10-22	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215168-001	NCE	2029-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215168-001	NCE	2029-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215168-001	NCE	2029-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215168-001	NCE	2029-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215168-001	NCE	2029-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215168-001	NCE	2029-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215168-001	NCE	2029-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215168-001	NCE	2029-09-27	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215168-001	NCE	2029-09-27	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215168-001	NCE	2029-09-27	`a50c72e98297…`

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
Flyrcado	FLURPIRIDAZ F-18	GE Healthcare Inc.	3bb6caf8-ac98-46c7-a9f0-961e66032705	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215168 application number: NDA215168

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79982	ORIG	2024-10-25
79777	ORIG	2024-09-30
79758	ORIG	2024-09-27