Home Applications 214375 Application 214375
Type NDA
Sponsor POLAREAN INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XENOVIEW XENON XE 129 HYPERPOLARIZED INHALANT;ORAL 1000ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N214375-001 XENOVIEW XENON XE-129 HYPERPOLARIZED N/A GAS / INHALATION RLD, RS 2022-12-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214375-001 10583205 2035-02-20 Drug product 2023-01-20 N214375-001 11052161 2035-12-29 Drug product 2023-01-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214375-001 NCE 2027-12-23
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 2026-02-19 14:30 UTC 2026-02 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214375-001 XENOVIEW N/A GAS / INHALATION RLD, RS 2022-12-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 46 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214375-001 10583205 2035-02-20 Drug product 2023-01-20 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214375-001 11052161 2035-12-29 Drug product 2023-01-20 a67488948f0b…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 80534-1000 XENOVIEW xenon Xe 129 hyperpolarized Polarean, Inc. NDA Current 80534-6350 XENOVIEW xenon Xe 129 hyperpolarized Polarean, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82427 SUPPL 2025-06-02 82424 SUPPL 2025-06-02 73281 ORIG 2023-01-24 73053 ORIG 2022-12-27 73030 ORIG 2022-12-23