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 3 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 2019-12-13 00:20 UTC 2019-12 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N017982-001 AMIPAQUE 3.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017982-002 AMIPAQUE 6.75GM/VIAL INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017982-003 AMIPAQUE 2.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N017982-004 AMIPAQUE 13.5GM/VIAL INJECTABLE / INJECTION 1983-09-12 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.