Home Applications 022066 Application 022066
Type NDA
Sponsor GE HEALTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMNISCAN GADODIAMIDE INJECTABLE;INJECTION 14.35GM/50ML (287MG/ML) No No 002 OMNISCAN GADODIAMIDE INJECTABLE;INJECTION 28.7GM/100ML (287MG/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 N022066-001 OMNISCAN GADODIAMIDE 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 N022066-002 OMNISCAN GADODIAMIDE 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05
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 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD 2007-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION 2007-09-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD, RS 2007-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION 2007-09-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD, RS 2007-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION 2007-09-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD, RS 2007-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION 2007-09-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD, RS 2007-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022066-001 OMNISCAN 14.35GM/50ML (287MG/ML) INJECTABLE / INJECTION 2007-09-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022066-002 OMNISCAN 28.7GM/100ML (287MG/ML) INJECTABLE / INJECTION RLD, RS 2007-09-05 bb7c543d1eb4…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OMNISCAN GADODIAMIDE GE Healthcare Inc. 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a 2025-04-18 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 0407-0690
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 0407-0690 OMNISCAN gadodiamide GE Healthcare Inc. NDA Current 0407-0690 OMNISCAN gadodiamide GE Healthcare Inc. NDA Current