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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Brilliant Blue G Ophthalmic Solution 0.025%
Trade Name: DORC ILM-Blue
Date Designated: 07/31/2012
Orphan Designation: For use as an aid in ophthalmic surgery by selectively staining the internal limiting membrane
Orphan Designation Status: Designated/Approved
Dutch Ophthalmic Research Center International BV
P.O. Box 43
Zuidland
Netherlands

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Brilliant Blue G Ophthalmic Solution 0.025%
Trade Name: DORC ILM-Blue
Marketing Approval Date: 12/20/2019
Approved Labeled Indication: TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is indicated to selectively stain the internal limiting membrane (ILM).
Exclusivity End Date: 12/20/2026 
Exclusivity Protected Indication* :  Indicated to selectively stain the internal limiting membrane (ILM)
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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