Home Applications 017982 Application 017982
Type NDA
Sponsor GE HEALTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMIPAQUE METRIZAMIDE INJECTABLE;INJECTION 3.75GM/VIAL No No 002 AMIPAQUE METRIZAMIDE INJECTABLE;INJECTION 6.75GM/VIAL No No 003 AMIPAQUE METRIZAMIDE INJECTABLE;INJECTION 2.5GM/VIAL No No 004 AMIPAQUE METRIZAMIDE INJECTABLE;INJECTION 13.5GM/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017982-001 AMIPAQUE METRIZAMIDE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 N017982-002 AMIPAQUE METRIZAMIDE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 N017982-003 AMIPAQUE METRIZAMIDE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 N017982-004 AMIPAQUE METRIZAMIDE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12
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 5 · 168 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 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 d8e5a09893c0…