FDA — authorised 12 March 2009
- Application: ANDA077764
- Marketing authorisation holder: RISING
- Local brand name: APRACLONIDINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 APRACLONIDINE HYDROCHLORIDE in United States
FDA authorised APRACLONIDINE HYDROCHLORIDE on 12 March 2009
Marketing authorisations
FDA
- Status: approved
APRACLONIDINE 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 APRACLONIDINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 12 March 2009; FDA has authorised it.
Who is the marketing authorisation holder for APRACLONIDINE HYDROCHLORIDE in United States?
RISING holds the US marketing authorisation.