Application 203937

Type: ANDA
Sponsor: HOT SHOTS NM LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	INJECTABLE;INTRAVENOUS	4-500mCi/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203937-001	FLUDEOXYGLUCOSE F18	FLUDEOXYGLUCOSE F-18	4-500mCi/ML	INJECTABLE / INTRAVENOUS			2014-10-30

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203937-001	FLUDEOXYGLUCOSE F18	4-500mCi/ML	INJECTABLE / INTRAVENOUS	2014-10-30	`cb3db0bc1861…`

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 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	Precision Nuclear, LLC	09ae2a6d-673a-423a-ba45-3c543061b103	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F-18	Biomedical Research Foundation of Northwest Louisiana	edb15e3c-848d-433d-9f1c-c73a3c72861b	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18 generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F 18	FLUDEOXYGLUCOSE F-18	Biomedical Research Foundation of Northwest Louisiana	1deaaa92-1c98-4295-8aa6-7a70bc29f55d	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F18	Kreitchman PET Center	1e415eb3-e8a5-4149-b4ec-ba9ab3b29d7f	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18
Fludeoxyglucose F 18	FLUDEOXYGLUCOSE F-18	Jubilant DraxImage Inc., dba Jubilant Radiopharma	5d05df4a-463e-4e66-9387-f3a842e20cd0	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F 18	FLUDEOXYGLUCOSE F-18	Kettering Medical Center	982b9df4-0772-4de1-a01e-794a77518500	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F18	3D Imaging Drug Design and Development LLC	2785ce60-86c9-42c2-ab0a-8c5d5adf60d3	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18
Fludeoxyglucose F 18	FLUDEOXYGLUCOSE F-18	Mayo Clinic	153b650d-7b69-4880-a72a-a5f13059d248	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F 18	FLUDEOXYGLUCOSE F-18	SOFIE Co.	2028be0c-333c-4e0c-be57-099276c725d7	2025-11-19	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F18	UCSF Radiopharmaceutical Facility	763958a2-6952-4c0d-8a4a-9c04acb62229	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F18	The Regents of the University of Michigan	35bfa064-4313-49e2-98d2-85a84d2c40a4	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F18	The University of Texas MD Anderson Cancer Center	43954e40-bb95-4275-92ab-96211b7de907	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18
Fludeoxyglucose F 18	FLUDEOXYGLUCOSE F-18	BAMF Health Inc.	347c6beb-499e-af61-e063-6394a90a6011	2025-03-11	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F18	MIPS Cyclotron & Radiochemistry Facility	0ec2d4d1-b295-18dc-e054-00144ff88e88	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18
Fludeoxyglucose F-18	FLUDEOXYGLUCOSE F-18	Trustees of the University of Pennsylvania	84f1aeab-685d-47fd-a8e9-e724979c4ce6	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F-18	FLUDEOXYGLUCOSE F-18	Barbara Ann Karmanos Cancer Hospital	e3791140-2e52-48c5-9849-536d5e4275e5	2022-11-10	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F 18	FLUDEOXYGLUCOSE F-18	UIHC-P E T IMAGING CENTER	4842b836-1a7c-4417-ab8d-aa37bf7065f8	2022-10-09	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F 18	FLUDEOXYGLUCOSE F-18	Massachusetts General Hospital	232fbb91-402e-44d8-a0cf-6813980b8ead	2021-11-25	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F-18	FLUDEOXYGLUCOSE F-18	BRIGHAM AND WOMEN`S HOSPITAL, INC., THE	6b7b71c9-f10c-4ace-8166-ea242d8e628d	2021-11-03	Warnings, Adverse reactions	Name fallback generic name: FLUDEOXYGLUCOSE F-18
Fludeoxyglucose F18	FLUDEOXYGLUCOSE F18	The Methodist Hospital Research Institute	195d1b07-5669-247f-e054-00144ff8d46c	2021-08-13	Warnings, Adverse reactions	Name fallback brand name: Fludeoxyglucose F18

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
76419-111	Fludeoxyglucose F 18	Fludeoxyglucose F 18	Hot Shots NM, LLC dba Midwest Positron Technology, LC	ANDA	Current
76419-111	Fludeoxyglucose F 18	Fludeoxyglucose F 18	Hot Shots NM, LLC dba Midwest Positron Technology, LC	ANDA	Current