FDA — authorised 15 September 2000
- Application: NDA021251
- Marketing authorisation holder: ABBVIE
- Local brand name: KALETRA
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Kaletra in United States
FDA authorised Kaletra on 15 September 2000
Marketing authorisations
FDA — authorised 15 September 2000
- Status: approved
FDA — authorised 15 September 2000
- Application: NDA021226
- Marketing authorisation holder: ABBVIE
- Local brand name: KALETRA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 2005
- Application: NDA021906
- Marketing authorisation holder: ABBVIE
- Local brand name: KALETRA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 June 2021
- Application: ANDA091677
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
FDA — authorised 21 March 2022
- Application: ANDA213857
- Marketing authorisation holder: LAURUS
- Status: approved
FDA — authorised 25 July 2024
- Application: ANDA204739
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
Kaletra in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Kaletra approved in United States?
Yes. FDA authorised it on 15 September 2000; FDA authorised it on 15 September 2000; FDA authorised it on 15 September 2000.
Who is the marketing authorisation holder for Kaletra in United States?
ABBVIE holds the US marketing authorisation.