Application 210265

Type: ANDA
Sponsor: UNIV TX SW MEDCTR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	INJECTABLE;INTRAVENOUS	20-200mCi/ML	No	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
A210265-001	FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	20-200mCi/ML	INJECTABLE / INTRAVENOUS			2020-02-06

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210265-001	FLUDEOXYGLUCOSE F18	20-200mCi/ML	INJECTABLE / INTRAVENOUS	2020-02-06	`a50c72e98297…`

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fludeoxyglucose F-18	FLUDEOXYGLUCOSE F-18	Cardinal Health 414, LLC	08044d8f-036c-4809-997f-dd5180feebe6	2020-12-04	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F18	THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH	dfd91498-4bfc-4d45-a9a3-cee6153ae573	2019-07-11	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70681-002	Fludeoxyglucose F-18	Fludeoxyglucose F-18	University of Texas Southwestern Medical Center, The	ANDA	Current
70681-002	Fludeoxyglucose F-18	Fludeoxyglucose F-18	The University of Texas Southwestern Medical Center	ANDA	Current
70681-002	Fludeoxyglucose F-18	Fludeoxyglucose F-18	The University of Texas Southwestern Medical Center	ANDA	Current