Application 214907

Type: NDA
Sponsor: ON TARGET LABROTORIES, INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYTALUX	PAFOLACIANINE	INJECTABLE;INJECTION	3.2MG/1.6ML (2MG/ML)	No	No

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
N214907-001	CYTALUX	PAFOLACIANINE SODIUM	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-11-29

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25
N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25
N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25
N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25
N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25
N214907-001	9061057	2035-11-29	U-3291	Drug substance, Drug product	2022-01-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214907-001	NCE	2026-11-29
N214907-001	ODE-390	2028-11-29

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
2026-09-14 22:38:34	2026-08	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214907-001	CYTALUX	EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-11-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 204 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	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	9061057	2035-11-29	U-3291	Drug substance, Drug product	2022-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	9061057	2035-11-29	U-3291	Drug substance, Drug product	2022-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9789208	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	9254341	2033-10-04		Drug substance, Drug product	2022-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	10881747	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	9061057	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	9333270	2033-08-26	U-3291	Drug substance, Drug product	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	9341629	2033-08-26		Drug substance, Drug product	2022-01-25	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N214907-001	NCE	2026-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214907-001	ODE-390	2028-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214907-001	NCE	2026-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214907-001	ODE-390	2028-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214907-001	NCE	2026-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214907-001	ODE-390	2028-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	I-905	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	NCE	2026-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214907-001	ODE-390	2028-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214907-001	I-905	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	NCE	2026-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214907-001	ODE-390	2028-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	I-905	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	NCE	2026-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214907-001	ODE-390	2028-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	I-905	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	NCE	2026-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214907-001	ODE-390	2028-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214907-001	I-905	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214907-001	NCE	2026-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214907-001	ODE-390	2028-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214907-001	I-905	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214907-001	NCE	2026-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214907-001	ODE-390	2028-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214907-001	I-905	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214907-001	NCE	2026-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214907-001	ODE-390	2028-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214907-001	I-905	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214907-001	NCE	2026-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214907-001	ODE-390	2028-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214907-001	I-905	2025-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214907-001	NCE	2026-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214907-001	ODE-390	2028-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214907-001	I-905	2025-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214907-001	NCE	2026-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214907-001	ODE-390	2028-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214907-001	I-905	2025-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214907-001	NCE	2026-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214907-001	ODE-390	2028-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214907-001	I-905	2025-12-16	`1e350fbaab3a…`

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
Cytalux	PAFOLACIANINE INJECTION	On Target Laboratories, Inc.	d21952b9-7c4e-3a56-e053-2a95a90a0ab0	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214907 application number: NDA214907 ndc (product): 81052-138

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
81052-138	Cytalux	Pafolacianine injection	On Target Laboratories, Inc.	NDA	Current
81052-138	Cytalux	Pafolacianine injection	On Target Laboratories, Inc.	NDA	Current
81052-138	Cytalux	Pafolacianine injection	On Target Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72927	SUPPL	2022-12-20
72926	SUPPL	2022-12-19
69746	ORIG	2021-12-22
69426	ORIG	2021-11-30
69422	ORIG	2021-11-30