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U.S. Department of Health and Human Services

Food Additive and Color Additive Petitions Under Review or Held in Abeyance

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CAP 0C0288

Use of C.I. Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo, disodium salt] (CAS Reg. No. 4499018) reacted with polyvinyl alcohol as a color additive in vascular embolization devices.

Petitioner: Biocompatibles UK Ltd.
Date of Filing: Jan 14, 2010
Status: held in abeyance
Status update date: Jul 6, 2010
Code of Federal Regulations (21 CFR) referenced: 73
Federal Register Citation: 75 FR 13556; Mar 22, 2010; Notice.
FDA Docket Number: FDA-2010-C-0077