Application 020372

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYOVIEW	TECHNETIUM TC-99M TETROFOSMIN KIT	INJECTABLE;INJECTION	N/A	Yes	No
002	MYOVIEW 30ML	TECHNETIUM TC-99M TETROFOSMIN KIT	INJECTABLE;INJECTION	N/A	Yes	Yes

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
N020372-001	MYOVIEW	TECHNETIUM TC-99M TETROFOSMIN KIT	N/A	INJECTABLE / INJECTION		RLD, RS	1996-02-09
N020372-002	MYOVIEW 30ML	TECHNETIUM TC-99M TETROFOSMIN KIT	N/A	INJECTABLE / INJECTION		RLD, RS	2005-07-07

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N020372-002	9549999	2030-03-10		Drug product	2017-12-04

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD, RS	1996-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD	1996-02-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020372-001	MYOVIEW	N/A	INJECTABLE / INJECTION	RLD	1996-02-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020372-002	MYOVIEW 30ML	N/A	INJECTABLE / INJECTION	RLD, RS	2005-07-07	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020372-002	9549999	2030-03-10	Drug product	2017-12-04	`e64feba35796…`

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
Myoview	TETROFOSMIN	Medi-Physics Inc. dba GE Healthcare	98c85037-a907-4a3a-8864-c3a5298b4759	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020372 application number: NDA020372 ndc (product): 17156-026
Myoview	TETROFOSMIN	Medi-Physics Inc. dba GE Healthcare	4a8e5ed7-57f4-4d48-93cd-5f307207a3a0	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020372 application number: NDA020372 ndc (product): 17156-024

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
17156-024	Myoview	Tetrofosmin	Medi-Physics Inc. dba GE Healthcare	NDA	Current
17156-024	Myoview	Tetrofosmin	Medi-Physics Inc. dba GE Healthcare	NDA	Current
17156-024	Myoview	Tetrofosmin	Medi-Physics Inc. dba GE Healthcare	NDA	Current
17156-026	Myoview	Tetrofosmin	Medi-Physics Inc. dba GE Healthcare	NDA	Current
17156-026	Myoview	Tetrofosmin	Medi-Physics Inc. dba GE Healthcare	NDA	Current
17156-026	Myoview	Tetrofosmin	Medi-Physics Inc. dba GE Healthcare	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72829	SUPPL	2022-12-08
72817	SUPPL	2022-12-07
70551	SUPPL	2022-03-17
70470	SUPPL	2022-03-10
48061	SUPPL	2017-04-18
48053	SUPPL	2017-04-18
34568	SUPPL	2009-03-17
24859	SUPPL	2009-03-05
24858	SUPPL	2005-07-15
12496	SUPPL	2005-07-15
34567	SUPPL	2003-12-01
2405	SUPPL	2003-11-26
20613	SUPPL	2003-07-08
12495	SUPPL	2003-04-22
2404	SUPPL	2003-03-10
34566	SUPPL	2003-03-05
24857	SUPPL	2002-05-22
20612	SUPPL	2002-03-12
34565	SUPPL	2001-11-03
2403	SUPPL	2001-11-03