Application 017284

Type: NDA
Sponsor: LANTHEUS MEDCL

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 44.

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
N017284-001	XENON XE 133	XENON XE-133	10mCi/VIAL	GAS / INHALATION		Approved before 1982
N017284-002	XENON XE 133	XENON XE-133	20mCi/VIAL	GAS / INHALATION		Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017284-001	XENON XE 133	10mCi/VIAL	GAS / INHALATION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017284-002	XENON XE 133	20mCi/VIAL	GAS / INHALATION	Approved before 1982	`3a93d1ddd44b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xenon	XENON XE-133	Shine Spect USA, LLC	74f95143-d3b4-4e69-b200-e09bf811516b	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017284 application number: NDA017284
Xenon	XENON XE-133	Lantheus Medical Imaging, Inc.	35bdc182-2a41-41d2-8fe7-aa0c140d4425	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017284 application number: NDA017284 ndc (product): 11994-127 ndc (product): 11994-128

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11994-127	Xenon	Xenon XE-133	Lantheus Medical Imaging, Inc.	NDA	Current
11994-127	Xenon	Xenon XE-133	Lantheus Medical Imaging, Inc.	NDA	Current
11994-127	Xenon	Xenon XE-133	Lantheus Medical Imaging, Inc.	NDA	Current
11994-128	Xenon	Xenon XE-133	Lantheus Medical Imaging, Inc.	NDA	Current
11994-128	Xenon	Xenon XE-133	Lantheus Medical Imaging, Inc.	NDA	Current
11994-128	Xenon	Xenon XE-133	Lantheus Medical Imaging, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
13106	SUPPL	2011-09-16
10974	SUPPL	2011-09-16
13105	SUPPL	2003-10-29