Application 204328

Type: ANDA
Sponsor: THE FEINSTEIN INST

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	INJECTABLE;INTRAVENOUS	20-600mCi/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204328-001	SODIUM FLUORIDE F-18	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS			2014-11-19

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204328-001	SODIUM FLUORIDE F-18	20-600mCi/ML	INJECTABLE / INTRAVENOUS	2014-11-19	`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
Sodium Fluoride F 18	SODIUM FLUORIDE F-18	BAMF Health Inc.	ef58c3cd-a922-c5fc-e053-2a95a90a9d74	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204328 application number: ANDA204328 ndc (product): 81759-002
Sodium Fluoride F 18	SODIUM FLUORIDE F 18	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	f8afb06c-f4c3-46f0-8f8b-0bc9e072ce47	2019-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204328 application number: ANDA204328 ndc (product): 13267-542

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
13267-542	Sodium Fluoride	Sodium Fluoride F 18	THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH	ANDA	Current
81759-002	Sodium Fluoride	SODIUM FLUORIDE F-18	BAMF Health Inc.	ANDA	Current