Home Applications 214511 Application 214511
Type NDA
Sponsor LUMICELL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LUMISIGHT PEGULICIANINE ACETATE POWDER;INTRAVENOUS EQ 39MG BASE/VIAL 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 N214511-001 LUMISIGHT PEGULICIANINE ACETATE EQ 39MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17
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 N214511-001 11592396 2030-09-01 Drug substance 2025-01-17 N214511-001 9155471 2031-10-12 U-3890 2024-05-01 N214511-001 10285759 2031-12-08 U-3890 2024-05-01 N214511-001 9032965 2031-12-08 U-3890 2024-05-01 N214511-001 9532835 2031-12-08 U-3890 2024-05-01 N214511-001 9763577 2034-09-14 U-3890 Drug substance, Drug product 2024-05-01
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214511-001 NCE 2029-04-17
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 2026-09-14 22:38:34 2026-08 N214511-001 LUMISIGHT EQ 39MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214511-001 LUMISIGHT EQ 39MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214511-001 LUMISIGHT EQ 39MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214511-001 LUMISIGHT EQ 39MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214511-001 LUMISIGHT EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214511-001 LUMISIGHT EQ 39MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2024-04-17 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 93 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 N214511-001 11592396 2030-09-01 Drug substance 2025-01-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214511-001 9155471 2031-10-12 U-3890 2024-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214511-001 10285759 2031-12-08 U-3890 2024-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214511-001 9032965 2031-12-08 U-3890 2024-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214511-001 9532835 2031-12-08 U-3890 2024-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214511-001 9763577 2034-09-14 U-3890 Drug substance, Drug product 2024-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214511-001 11592396 2030-09-01 Drug substance 2025-01-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214511-001 9155471 2031-10-12 U-3890 2024-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214511-001 10285759 2031-12-08 U-3890 2024-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214511-001 9032965 2031-12-08 U-3890 2024-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214511-001 9532835 2031-12-08 U-3890 2024-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214511-001 9763577 2034-09-14 U-3890 Drug substance, Drug product 2024-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214511-001 11592396 2030-09-01 Drug substance 2025-01-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214511-001 9155471 2031-10-12 U-3890 2024-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214511-001 10285759 2031-12-08 U-3890 2024-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214511-001 9032965 2031-12-08 U-3890 2024-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214511-001 9532835 2031-12-08 U-3890 2024-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214511-001 9763577 2034-09-14 U-3890 Drug substance, Drug product 2024-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214511-001 11592396 2030-09-01 Drug substance 2025-01-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214511-001 9155471 2031-10-12 U-3890 2024-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214511-001 10285759 2031-12-08 U-3890 2024-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214511-001 9032965 2031-12-08 U-3890 2024-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214511-001 9532835 2031-12-08 U-3890 2024-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214511-001 9763577 2034-09-14 U-3890 Drug substance, Drug product 2024-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214511-001 11592396 2030-09-01 Drug substance 2025-01-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214511-001 9155471 2031-10-12 U-3890 2024-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214511-001 10285759 2031-12-08 U-3890 2024-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214511-001 9032965 2031-12-08 U-3890 2024-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214511-001 9532835 2031-12-08 U-3890 2024-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214511-001 9763577 2034-09-14 U-3890 Drug substance, Drug product 2024-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214511-001 11592396 2030-09-01 Drug substance 2025-01-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214511-001 9155471 2031-10-12 U-3890 2024-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214511-001 10285759 2031-12-08 U-3890 2024-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214511-001 9032965 2031-12-08 U-3890 2024-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214511-001 9532835 2031-12-08 U-3890 2024-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214511-001 9763577 2034-09-14 U-3890 Drug substance, Drug product 2024-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214511-001 11592396 2030-09-01 Drug substance 2025-01-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214511-001 9155471 2031-10-12 U-3890 2024-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214511-001 10285759 2031-12-08 U-3890 2024-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214511-001 9032965 2031-12-08 U-3890 2024-05-01 b8a1b40f171c…
Observed Orange Book exclusivity history# 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 LUMISIGHT PEGULICIANINE Lumicell, Inc. 7160e774-663a-43e4-ba4a-06cc57830e66 2026-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 214511 application number: NDA214511
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 78384 ORIG 2024-05-03 78155 ORIG 2024-04-17 78154 ORIG 2024-04-17