FDA — authorised 31 July 1974
- Marketing authorisation holder: ALCON LABS INC
- Status: approved
🇺🇸 Cyclogyl in United States
FDA authorised Cyclogyl on 31 July 1974
Marketing authorisations
FDA — authorised 31 July 1974
- Application: ANDA084110
- Marketing authorisation holder: ALCON LABS INC
- Local brand name: CYCLOGYL
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 July 1974
- Application: ANDA084108
- Marketing authorisation holder: ALCON LABS INC
- Local brand name: CYCLOGYL
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 July 1974
- Application: ANDA084109
- Marketing authorisation holder: ALCON LABS INC
- Local brand name: CYCLOGYL
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 24 December 1996
- Application: ANDA084300
- Marketing authorisation holder: ALCON LABS INC
- Indication: Labeling
- Status: approved
FDA — authorised 10 February 1998
- Application: ANDA040075
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
Cyclogyl in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Ophthalmology approved in United States
Frequently asked questions
Is Cyclogyl approved in United States?
Yes. FDA authorised it on 31 July 1974; FDA authorised it on 31 July 1974; FDA authorised it on 31 July 1974.
Who is the marketing authorisation holder for Cyclogyl in United States?
ALCON LABS INC holds the US marketing authorisation.