FDA — authorised 20 February 2009
- Application: NDA022278
- Marketing authorisation holder: DORC
- Local brand name: MEMBRANEBLUE
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
🇺🇸 TRYPAN BLUE in United States
FDA authorised TRYPAN BLUE on 20 February 2009 · 69 US adverse-event reports
Marketing authorisations
FDA — authorised 17 April 2015
- Application: NDA021670
- Marketing authorisation holder: DORC
- Indication: Manufacturing (CMC)
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 69
Most-reported reactions
- Blindness — 21 reports (30.43%)
- Toxic Anterior Segment Syndrome — 21 reports (30.43%)
- Corneal Oedema — 6 reports (8.7%)
- Product Quality Issue — 6 reports (8.7%)
- Cerebral Infarction — 3 reports (4.35%)
- Pigmentation Disorder — 3 reports (4.35%)
- Thyroid Disorder — 3 reports (4.35%)
- Condition Aggravated — 2 reports (2.9%)
- Off Label Use — 2 reports (2.9%)
- Vision Blurred — 2 reports (2.9%)
TRYPAN BLUE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is TRYPAN BLUE approved in United States?
Yes. FDA authorised it on 20 February 2009; FDA authorised it on 17 April 2015.
Who is the marketing authorisation holder for TRYPAN BLUE in United States?
DORC holds the US marketing authorisation.