Application 203137

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIZAMYL	FLUTEMETAMOL F-18	INJECTABLE;INTRAVENOUS	40.5mCi/10ML (4.05mCi/ML)	Yes	No
002	VIZAMYL	FLUTEMETAMOL F-18	INJECTABLE;INTRAVENOUS	121.5mCi/30ML (4.05mCi/ML)	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
N203137-001	VIZAMYL	FLUTEMETAMOL F-18	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS		RLD	2013-10-25
N203137-002	VIZAMYL	FLUTEMETAMOL F-18	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2013-10-25

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
N203137-001	8916131	2028-09-16		Drug product	2015-02-18
N203137-002	8916131	2028-09-16		Drug product	2015-02-18

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	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203137-001	VIZAMYL	40.5mCi/10ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD	2013-10-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203137-002	VIZAMYL	121.5mCi/30ML (4.05mCi/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2013-10-25	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203137-001	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203137-002	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203137-001	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203137-002	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203137-001	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203137-002	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203137-001	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203137-002	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203137-001	8236282	2024-05-21		Drug substance, Drug product	2013-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203137-001	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203137-002	8236282	2024-05-21		Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203137-002	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203137-001	8236282	2024-05-21		Drug substance, Drug product	2013-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203137-001	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203137-002	8236282	2024-05-21		Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203137-002	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203137-001	8236282	2024-05-21		Drug substance, Drug product	2013-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203137-001	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203137-001	8916131	2028-09-16		Drug product	2015-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203137-002	8236282	2024-05-21		Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203137-002	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203137-002	8916131	2028-09-16		Drug product	2015-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203137-001	8236282	2024-05-21		Drug substance, Drug product	2013-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203137-001	7270800	2025-09-03	U-336	Drug substance, Drug product	2014-03-28	`d8e5a09893c0…`

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
Vizamyl	FLUTEMETAMOL F-18	GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)	b3558f16-8f9a-4e55-8d9c-836427ebaa57	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203137 application number: NDA203137 ndc (product): 17156-067

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
17156-067	Vizamyl	Flutemetamol F-18	Medi-Physics, Inc. dba GE Healthcare	NDA	Current
17156-067	Vizamyl	Flutemetamol F-18	Medi-Physics, Inc. dba GE Healthcare	NDA	Current
17156-067	Vizamyl	Flutemetamol F-18	Medi-Physics, Inc. dba GE Healthcare	NDA	Current
17156-067	Vizamyl	Flutemetamol F-18	Medi-Physics, Inc. dba GE Healthcare	NDA	Current
17156-067	Vizamyl	Flutemetamol F-18	Medi-Physics, Inc. dba GE Healthcare	NDA	Current
17156-067	Vizamyl	Flutemetamol F-18	Medi-Physics, Inc. dba GE Healthcare	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82682	SUPPL	2025-06-27
82653	SUPPL	2025-06-24
82542	SUPPL	2025-06-12
82541	SUPPL	2025-06-11
61571	SUPPL	2020-01-14
61562	SUPPL	2020-01-14
47303	SUPPL	2017-02-23
47300	SUPPL	2017-02-23
10169	SUPPL	2016-04-11
19432	SUPPL	2016-04-08
19431	SUPPL	2014-12-10
10168	SUPPL	2014-12-05
43421	ORIG	2013-11-15
19430	ORIG	2013-10-31
32382	ORIG	2013-10-29