Application 200655

Type: NDA
Sponsor: FEINSTEIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUORODOPA F18	FLUORODOPA F-18	SOLUTION;INTRAVENOUS	0.42-8.33mCi/ML	Yes	Yes
002	FLUORODOPA F18	FLUORODOPA F-18	SOLUTION;INTRAVENOUS	1-40mCi/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200655-001	FLUORODOPA F18	FLUORODOPA F-18	1-40mCi/ML	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-10

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200655-001	FLUORODOPA F18	1-40mCi/ML	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-10	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200655-001	NCE	2024-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200655-001	W	2024-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200655-001	NCE	2024-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200655-001	W	2024-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200655-001	NCE	2024-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200655-001	W	2024-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200655-001	NCE	2024-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200655-001	W	2024-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200655-001	NCE	2024-10-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200655-001	W	2024-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200655-001	NCE	2024-10-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200655-001	W	2024-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200655-001	NCE	2024-10-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200655-001	W	2024-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200655-001	NCE	2024-10-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200655-001	W	2024-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200655-001	NCE	2024-10-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N200655-001	W	2024-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200655-001	NCE	2024-10-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200655-001	W	2024-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200655-001	NCE	2024-10-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N200655-001	W	2024-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200655-001	NCE	2024-10-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N200655-001	W	2024-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200655-001	NCE	2024-10-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200655-001	W	2024-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200655-001	NCE	2024-10-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N200655-001	W	2024-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200655-001	NCE	2024-10-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200655-001	W	2024-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200655-001	NCE	2024-10-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200655-001	W	2024-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200655-001	NCE	2024-10-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200655-001	W	2024-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200655-001	NCE	2024-10-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200655-001	W	2024-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200655-001	NCE	2024-10-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N200655-001	W	2024-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200655-001	NCE	2024-10-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200655-001	W	2024-10-10	`3f01610625f2…`

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
Fluorodopa F18	FLUORODOPA F18	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	37f8c405-ccb6-4fcd-8513-108956bb1674	2021-01-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200655 application number: NDA200655 ndc (product): 13267-346
Fluorodopa F18	FLUORODOPA F18	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	262503e7-de09-4b42-9963-ec00cbc7c35c	2019-10-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200655 application number: NDA200655 ndc (product): 13267-345

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13267-345	Fluorodopa	Fluorodopa F18	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	NDA	Current
13267-346	Fluorodopa	Fluorodopa F18	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81245	SUPPL	2020-12-11
81244	SUPPL	2020-12-11
60993	ORIG	2019-11-20
60538	ORIG	2019-10-11
60537	ORIG	2019-10-11