Application 018327

Type: NDA
Sponsor: CURIUM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XENON XE 133	XENON XE-133	GAS;INHALATION	10mCi/VIAL	No	No
002	XENON XE 133	XENON XE-133	GAS;INHALATION	20mCi/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018327-001	XENON XE 133	XENON XE-133	10mCi/VIAL	GAS / INHALATION			1982-03-09
N018327-002	XENON XE 133	XENON XE-133	20mCi/VIAL	GAS / INHALATION			1982-03-09

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018327-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	1982-03-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018327-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	1982-03-09	`bb7c543d1eb4…`

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
Xenon, Xe-133	XENON	Curium US LLC	5eb971be-8808-4aeb-9898-0d22d5dffe04	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018327 application number: NDA018327 ndc (product): 69945-098 ndc (product): 69945-097

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
69945-097	Xenon, Xe-133	Xenon	Curium US LLC	NDA	Current
69945-097	Xenon, Xe-133	Xenon	Curium US LLC	NDA	Current
69945-097	Xenon, Xe-133	Xenon	Curium US LLC	NDA	Current
69945-098	Xenon, Xe-133	Xenon	Curium US LLC	NDA	Current
69945-098	Xenon, Xe-133	Xenon	Curium US LLC	NDA	Current
69945-098	Xenon, Xe-133	Xenon	Curium US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11204	SUPPL	2016-03-14