Home Applications 217737 Application 217737
Type ANDA
Sponsor AMNEAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IOHEXOL IOHEXOL SOLUTION;INJECTION, ORAL, RECTAL 64.7% No No
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 A217737-001 IOHEXOL IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 A217737-002 IOHEXOL IOHEXOL 75.5% SOLUTION / INJECTION, ORAL AP 2026-06-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A217737-001 CGT 2026-07-26
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 2026-08-18 06:07:40 2026-07 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217737-002 IOHEXOL 75.5% SOLUTION / INJECTION, ORAL AP 2026-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217737-001 IOHEXOL 64.7% SOLUTION / INJECTION, ORAL, RECTAL AP 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217737-002 IOHEXOL 75.5% SOLUTION / INJECTION, ORAL AP 2026-06-25 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 A217737-001 CGT 2026-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217737-001 CGT 2026-07-26 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217737-001 CGT 2026-07-26 a50c72e98297…
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 Iohexol IOHEXOL Amneal Pharmaceuticals Private Limited ff9456ef-c45a-450d-9004-a684af2bcc59 2026-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217737 application number: ANDA217737
Documents# Document, Submission type, Date table Document Submission type Date 84747 ORIG 2026-01-13