FDA — authorised 28 May 2004
- Application: ANDA076104
- Marketing authorisation holder: SANDOZ
- Local brand name: ITRACONAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Lozanoc in United States
FDA authorised Lozanoc on 28 May 2004
Marketing authorisations
FDA — authorised 30 October 2015
- Application: ANDA205573
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ITRACONAZOLE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 May 2016
- Application: ANDA205991
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ITRACONAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 September 2016
- Application: ANDA205080
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ITRACONAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 December 2016
- Application: ANDA206741
- Marketing authorisation holder: ALEMBIC
- Local brand name: ITRACONAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 June 2017
- Application: ANDA208591
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ITRACONAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 September 2017
- Application: ANDA204672
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ITRACONAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 August 2018
- Application: ANDA209460
- Marketing authorisation holder: TORRENT
- Local brand name: ITRACONAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 July 2019
- Application: ANDA206410
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: ITRACONAZOLE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Lozanoc in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Lozanoc approved in United States?
Yes. FDA authorised it on 28 May 2004; FDA authorised it on 30 October 2015; FDA authorised it on 26 May 2016.
Who is the marketing authorisation holder for Lozanoc in United States?
SANDOZ holds the US marketing authorisation.