Home Applications 218749 Application 218749
Type ANDA
Sponsor HAINAN POLY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GADOTERIDOL GADOTERIDOL INJECTABLE;INJECTION 279.3MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218749-001 GADOTERIDOL GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218749-001 AP
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.
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 2026-02-19 14:30 UTC 2026-02 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 a50c72e98297…
Observed Orange Book normalized TE 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GADOTERIDOL GADOTERIDOL Slate Run Pharmaceuticals, LLC 538a70e0-061c-40d2-8447-5b7a4e61a55f 2025-09-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 218749 application number: ANDA218749
Documents# Document, Submission type, Date table Document Submission type Date 81468 ORIG 2025-03-06