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 44 .
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 2 of 5 · 176 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 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…2024-10-29 15:01 UTC 2024-10 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 4b0b4de00fa7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.