FDA — authorised 22 November 1974
- Application: ANDA084150
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: CYCLOPENTOLATE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 CYCLOPENTOLATE HYDROCHLORIDE in United States
FDA authorised CYCLOPENTOLATE HYDROCHLORIDE on 22 November 1974 · 240 US adverse-event reports
Marketing authorisations
FDA — authorised 10 April 1979
- Application: ANDA085555
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: AK-PENTOLATE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 April 1994
- Application: ANDA040075
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: PENTOLAIR
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 9 December 2015
- Application: ANDA205937
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CYCLOPENTOLATE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA084863
- Marketing authorisation holder: SOLA BARNES HIND
- Local brand name: CYCLOPENTOLATE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA088643
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: PENTOLAIR
- Indication: SOLUTION/DROPS — OPHTHALMIC
- 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: 240
Most-reported reactions
- Dizziness — 34 reports (14.17%)
- Eye Pain — 29 reports (12.08%)
- Nausea — 28 reports (11.67%)
- Keratopathy — 27 reports (11.25%)
- Headache — 25 reports (10.42%)
- Toxic Anterior Segment Syndrome — 21 reports (8.75%)
- Dyspnoea — 20 reports (8.33%)
- Back Pain — 19 reports (7.92%)
- Visual Impairment — 19 reports (7.92%)
- Drug Ineffective — 18 reports (7.5%)
CYCLOPENTOLATE HYDROCHLORIDE 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 CYCLOPENTOLATE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 22 November 1974; FDA authorised it on 10 April 1979; FDA authorised it on 29 April 1994.
Who is the marketing authorisation holder for CYCLOPENTOLATE HYDROCHLORIDE in United States?
SOLA BARNES HIND holds the US marketing authorisation.