FDA — authorised 12 September 1945
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Status: approved
🇺🇸 Klaron in United States
FDA authorised Klaron on 12 September 1945
Marketing authorisations
FDA — authorised 29 December 1995
- Application: ANDA074449
- Marketing authorisation holder: BAUSCH AND LOMB
- Status: approved
FDA — authorised 23 December 1996
- Application: NDA019931
- Marketing authorisation holder: BAUSCH
- Local brand name: KLARON
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 19 November 1998
- Application: ANDA040066
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 29 April 2015
- Application: ANDA078649
- Marketing authorisation holder: PADAGIS US
- Indication: Labeling
- Status: approved
Klaron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Klaron approved in United States?
Yes. FDA authorised it on 12 September 1945; FDA authorised it on 29 December 1995; FDA authorised it on 23 December 1996.
Who is the marketing authorisation holder for Klaron in United States?
ORTHO MCNEIL PHARM holds the US marketing authorisation.