FDA — authorised 14 March 2011
- Application: ANDA090870
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: EPINASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 EPINASTINE HYDROCHLORIDE in United States
FDA authorised EPINASTINE HYDROCHLORIDE on 14 March 2011
Marketing authorisations
FDA — authorised 31 October 2011
- Application: ANDA090951
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: EPINASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 October 2011
- Application: ANDA091626
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: EPINASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 October 2011
- Application: ANDA090919
- Marketing authorisation holder: APOTEX
- Local brand name: EPINASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 7 December 2016
- Application: ANDA203384
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: EPINASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 May 2017
- Application: ANDA204055
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: EPINASTINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA090950
- Marketing authorisation holder: SANDOZ
- Local brand name: EPINASTINE HYDROCHLORIDE
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
FDA
- Status: approved
Frequently asked questions
Is EPINASTINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 14 March 2011; FDA authorised it on 31 October 2011; FDA authorised it on 31 October 2011.
Who is the marketing authorisation holder for EPINASTINE HYDROCHLORIDE in United States?
PHARMOBEDIENT holds the US marketing authorisation.