Home Applications 021870 Application 021870
Type NDA
Sponsor FEINSTEIN 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 Yes No 002 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-400mCi/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021870-001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 N021870-002 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021870-002 AP
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 3 · 84 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 2026-08-18 06:07:40 2026-07 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS RLD 2005-08-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS RLD 2005-08-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML INJECTABLE / INTRAVENOUS RLD 2005-08-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021870-001 FLUDEOXYGLUCOSE F18 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-08-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021870-002 FLUDEOXYGLUCOSE F18 20-400mCi/ML INJECTABLE / INTRAVENOUS AP RLD, RS 2008-11-21 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 13267-123 Fludeoxyglucose F18 Fludeoxyglucose F18 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH NDA Current 13267-234 Fludeoxyglucose Fludeoxyglucose F18 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH NDA Current 13267-234 Fludeoxyglucose Fludeoxyglucose F18 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH NDA Current 13267-234 Fludeoxyglucose Fludeoxyglucose F18 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76610 SUPPL 2023-11-17 76561 SUPPL 2023-11-14 59228 SUPPL 2019-07-03 59199 SUPPL 2019-06-28 59194 SUPPL 2019-06-28 16489 SUPPL 2012-01-23 28746 SUPPL 2012-01-20 28745 SUPPL 2011-01-07 16488 SUPPL 2011-01-06 37795 SUPPL 2010-08-20 6346 SUPPL 2010-08-20 21849 ORIG 2007-07-18 37794 ORIG 2005-08-23 6345 ORIG 2005-08-23