Home Applications 214907 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 44 .
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N214907-001 CYTALUX EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2021-11-29 c2088c7a36db…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 6 of 6 · 210 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214907-001 9333270 2033-08-26 U-3291 Drug substance, Drug product 2022-01-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214907-001 9341629 2033-08-26 Drug substance, Drug product 2022-01-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214907-001 9789208 2033-08-26 U-3291 Drug substance, Drug product 2022-01-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214907-001 9254341 2033-10-04 Drug substance, Drug product 2022-01-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214907-001 10881747 2033-08-26 U-3291 Drug substance, Drug product 2022-01-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214907-001 9333270 2033-08-26 U-3291 Drug substance, Drug product 2022-01-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214907-001 9341629 2033-08-26 Drug substance, Drug product 2022-01-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214907-001 9789208 2033-08-26 U-3291 Drug substance, Drug product 2022-01-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214907-001 9254341 2033-10-04 Drug substance, Drug product 2022-01-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214907-001 9061057 2035-11-29 U-3291 Drug substance, Drug product 2022-01-25 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 82 observed states.
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
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 · 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