Application 022555

Type: NDA
Sponsor: PHOTOCURE ASA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYSVIEW KIT	HEXAMINOLEVULINATE HYDROCHLORIDE	FOR SOLUTION;INTRAVESICAL	100MG/VIAL	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
N022555-001	CYSVIEW KIT	HEXAMINOLEVULINATE HYDROCHLORIDE	100MG/VIAL	FOR SOLUTION / INTRAVESICAL		RLD, RS	2010-05-28

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022555-001	10556010	2036-12-19	U-2250	2020-03-10
N022555-001	11311620	2036-12-19	U-2250	2022-05-20
N022555-001	11235168	2038-01-04	U-2250	2022-02-15

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022555-001	CYSVIEW KIT	100MG/VIAL	FOR SOLUTION / INTRAVESICAL	RLD, RS	2010-05-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022555-001	11311620	2036-12-19	U-2250	2022-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022555-001	11235168	2038-01-04	U-2250	2022-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022555-001	10556010	2036-12-19	U-2250	2020-03-10	`1e350fbaab3a…`

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	N022555-001	M-220	2021-02-15	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022555-001	M-220	2021-02-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022555-001	M-220	2021-02-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022555-001	M-220	2021-02-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022555-001	M-220	2021-02-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022555-001	M-220	2021-02-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022555-001	M-220	2021-02-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022555-001	M-220	2021-02-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022555-001	M-220	2021-02-15	`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
Cysview	HEXAMINOLEVULINATE HYDROCHLORIDE	Photocure Inc.	5aeed40d-6841-4adf-8940-f51d439fdfa3	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022555 application number: NDA022555 ndc (product): 10511-3001

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
10511-3001	Cysview	Hexaminolevulinate hydrochloride	Photocure ASA	NDA	Current
10511-3001	Cysview	Hexaminolevulinate hydrochloride	Photocure ASA	NDA	Current
10511-3001	Cysview	Hexaminolevulinate hydrochloride	Photocure ASA	NDA	Current
10511-3001	Cysview	Hexaminolevulinate hydrochloride	Photocure Inc.	NDA	Current
10511-3001	Cysview	Hexaminolevulinate hydrochloride	Photocure Inc.	NDA	Current
10511-3001	Cysview	Hexaminolevulinate hydrochloride	Photocure Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52706	SUPPL	2018-02-23
52659	SUPPL	2018-02-16
17703	SUPPL	2016-08-02
24338	ORIG	2011-07-20
22054	ORIG	2011-07-20
29854	ORIG	2010-06-08
17702	ORIG	2010-06-03