Home Applications 020808 Application 020808
Type NDA
Sponsor GE HEALTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VISIPAQUE 270 IODIXANOL INJECTABLE;INJECTION 55% No No 002 VISIPAQUE 320 IODIXANOL INJECTABLE;INJECTION 65.2% No No
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 N020808-001 VISIPAQUE 270 IODIXANOL 55% INJECTABLE / INJECTION 1997-08-29 N020808-002 VISIPAQUE 320 IODIXANOL 65.2% INJECTABLE / INJECTION 1997-08-29
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 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020808-001 VISIPAQUE 270 55% INJECTABLE / INJECTION 1997-08-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020808-002 VISIPAQUE 320 65.2% INJECTABLE / INJECTION 1997-08-29 bb7c543d1eb4…
Observed Orange Book exclusivity history# 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.
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 0407-2223 Visipaque Iodixanol GE Healthcare Inc. NDA Current 0407-2223 Visipaque Iodixanol GE Healthcare Inc. NDA Current 0407-2223 Visipaque Iodixanol GE Healthcare Inc. NDA Current 0407-2223 Visipaque Iodixanol GE Healthcare Inc. NDA Current