Application 021064

Type: NDA
Sponsor: LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEFINITY	PERFLUTREN	INJECTABLE;INTRAVENOUS	6.52MG/ML	Yes	Yes
002	DEFINITY RT	PERFLUTREN	INJECTABLE;INTRAVENOUS	6.52MG/ML	Yes	Yes

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
N021064-001	DEFINITY	PERFLUTREN	13.04MG/2ML (6.52MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2001-07-31
N021064-002	DEFINITY RT	PERFLUTREN	13.04MG/2ML (6.52MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2020-11-17

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021064-001	10583207	2035-12-28	U-665		2020-04-08
N021064-001	10583208	2037-03-16	U-665		2020-04-08
N021064-001	11266750	2037-03-16	U-665		2022-03-18
N021064-001	11529431	2037-03-16	U-665		2023-01-09
N021064-001	11857646	2037-03-16	U-665		2024-01-12
N021064-001	11925695	2037-03-16	U-665		2024-03-22
N021064-001	12161730	2037-03-16	U-665		2025-01-06
N021064-001	9789210	2037-03-16	U-665		2017-10-19
N021064-001	10588988	2037-05-04	U-665		2020-04-08
N021064-002	10022460	2035-12-28		Drug substance, Drug product	2020-12-16
N021064-002	10583207	2035-12-28	U-665		2020-12-16
N021064-002	11395856	2035-12-28	U-665	Drug substance, Drug product	2022-08-18
N021064-002	10583208	2037-03-16	U-665		2020-12-16
N021064-002	11266750	2037-03-16	U-665		2022-03-18
N021064-002	11529431	2037-03-16	U-665		2023-01-09
N021064-002	11857646	2037-03-16	U-665		2024-01-12
N021064-002	11925695	2037-03-16	U-665		2024-03-22
N021064-002	12161730	2037-03-16	U-665		2025-01-06
N021064-002	9789210	2037-03-16	U-665		2020-12-16
N021064-002	10588988	2037-05-04	U-665		2020-12-16

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021064-001	DEFINITY	13.04MG/2ML (6.52MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021064-002	DEFINITY RT	13.04MG/2ML (6.52MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021064-001	DEFINITY	13.04MG/2ML (6.52MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021064-002	DEFINITY RT	13.04MG/2ML (6.52MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021064-001	DEFINITY	13.04MG/2ML (6.52MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021064-002	DEFINITY RT	13.04MG/2ML (6.52MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021064-001	DEFINITY	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2001-07-31	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021064-002	DEFINITY RT	6.52MG/ML	INJECTABLE / INTRAVENOUS	RLD, RS	2020-11-17	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 612 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021064-001	10583207	2035-12-28	U-665		2020-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-001	10583208	2037-03-16	U-665		2020-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-001	11266750	2037-03-16	U-665		2022-03-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-001	11529431	2037-03-16	U-665		2023-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-001	11857646	2037-03-16	U-665		2024-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-001	11925695	2037-03-16	U-665		2024-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-001	12161730	2037-03-16	U-665		2025-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-001	9789210	2037-03-16	U-665		2017-10-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-001	10588988	2037-05-04	U-665		2020-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	10022460	2035-12-28		Drug substance, Drug product	2020-12-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	10583207	2035-12-28	U-665		2020-12-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	11395856	2035-12-28	U-665	Drug substance, Drug product	2022-08-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	10583208	2037-03-16	U-665		2020-12-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	11266750	2037-03-16	U-665		2022-03-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	11529431	2037-03-16	U-665		2023-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	11857646	2037-03-16	U-665		2024-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	11925695	2037-03-16	U-665		2024-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	12161730	2037-03-16	U-665		2025-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	9789210	2037-03-16	U-665		2020-12-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021064-002	10588988	2037-05-04	U-665		2020-12-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021064-001	10583207	2035-12-28	U-665		2020-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-001	10583208	2037-03-16	U-665		2020-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-001	11266750	2037-03-16	U-665		2022-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-001	11529431	2037-03-16	U-665		2023-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-001	11857646	2037-03-16	U-665		2024-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-001	11925695	2037-03-16	U-665		2024-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-001	12161730	2037-03-16	U-665		2025-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-001	9789210	2037-03-16	U-665		2017-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-001	10588988	2037-05-04	U-665		2020-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	10022460	2035-12-28		Drug substance, Drug product	2020-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	10583207	2035-12-28	U-665		2020-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	11395856	2035-12-28	U-665	Drug substance, Drug product	2022-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	10583208	2037-03-16	U-665		2020-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	11266750	2037-03-16	U-665		2022-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	11529431	2037-03-16	U-665		2023-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	11857646	2037-03-16	U-665		2024-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	11925695	2037-03-16	U-665		2024-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	12161730	2037-03-16	U-665		2025-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	9789210	2037-03-16	U-665		2020-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021064-002	10588988	2037-05-04	U-665		2020-12-16	`84e616aacf4f…`

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
DEFINITY RT	PERFLUTREN	Lantheus Medical Imaging, Inc.	7b9de6ab-a3ac-40c9-8103-139dc7a464a2	2024-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021064 application number: NDA021064 ndc (product): 11994-017
Definity	PERFLUTREN	Lantheus Medical Imaging, Inc.	8ab9c79c-1b5c-4e86-899c-cc74686f070a	2024-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021064 application number: NDA021064 ndc (product): 11994-011

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-011	Definity	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-017	DEFINITY RT	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-017	DEFINITY RT	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current
11994-017	DEFINITY RT	perflutren	Lantheus Medical Imaging, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77703	SUPPL	2024-03-04
77694	SUPPL	2024-03-04
74448	SUPPL	2023-06-06
74434	SUPPL	2023-06-06
67030	SUPPL	2021-04-13
67029	SUPPL	2021-04-13
67020	SUPPL	2021-04-12
67019	SUPPL	2021-04-12
66317	SUPPL	2021-02-22
65282	SUPPL	2020-11-19
65263	SUPPL	2020-11-18
64170	SUPPL	2020-08-03
64156	SUPPL	2020-07-31
57145	SUPPL	2019-01-09
56856	SUPPL	2018-12-20
46939	SUPPL	2017-01-24
46938	SUPPL	2017-01-24
26610	SUPPL	2015-08-20
14267	SUPPL	2015-08-19
44635	SUPPL	2012-08-14
21401	SUPPL	2012-08-14
26609	SUPPL	2011-10-26
14266	SUPPL	2011-10-25
14265	SUPPL	2008-06-05
4185	SUPPL	2008-05-14
4184	SUPPL	2007-10-15
14264	SUPPL	2007-10-10
14263	SUPPL	2007-10-04
4183	SUPPL	2004-06-02
23621	ORIG	2003-11-20
4182	SUPPL	2002-07-08
26608	SUPPL	2002-02-21
41917	ORIG	2001-07-31
26607	ORIG	2001-07-31
14262	ORIG	2001-07-31