Home Applications 203603 Application 203603
Type ANDA
Sponsor CARDINAL HEALTH 414 Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML No No 002 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-500mCi/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203603-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 A203603-002 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 75 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 2026-02-19 14:30 UTC 2026-02 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP RS 2018-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2018-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2018-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2018-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2018-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2018-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203603-002 FLUDEOXYGLUCOSE F18 20-500mCi/ML INJECTABLE / INTRAVENOUS AP 2018-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203603-001 FLUDEOXYGLUCOSE F18 20-300mCi/ML INJECTABLE / INTRAVENOUS AP 2015-11-13 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 observed states.
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.
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 65857-150 Fludeoxyglucose F-18 Fludeoxyglucose F-18 Cardinal Health 414, LLC ANDA Current 65857-150 Fludeoxyglucose F-18 Fludeoxyglucose F-18 Cardinal Health 414, LLC ANDA Current