FDA — authorised 7 February 2012
- Application: NDA202736
- Marketing authorisation holder: ARBOR PHARMS LLC
- Local brand name: SKLICE
- Indication: LOTION — TOPICAL
- Status: approved
🇺🇸 Ivermectin Lotion, 0.5% in United States
FDA authorised Ivermectin Lotion, 0.5% on 7 February 2012
Marketing authorisations
FDA — authorised 24 October 2014
- Application: ANDA204154
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Local brand name: IVERMECTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2019
- Application: ANDA210019
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: IVERMECTIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 13 April 2020
- Application: ANDA210225
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: IVERMECTIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 May 2020
- Application: ANDA210720
- Marketing authorisation holder: TARO
- Local brand name: IVERMECTIN
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 21 March 2022
- Application: ANDA212485
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: IVERMECTIN
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 2 August 2022
- Application: ANDA215210
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: IVERMECTIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 16 October 2024
- Application: ANDA218324
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: IVERMECTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 September 2025
- Application: ANDA218805
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: IVERMECTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2026
- Application: ANDA216863
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: IVERMECTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2026
- Application: ANDA218509
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: IVERMECTIN
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is Ivermectin Lotion, 0.5% approved in United States?
Yes. FDA authorised it on 7 February 2012; FDA authorised it on 24 October 2014; FDA authorised it on 13 September 2019.
Who is the marketing authorisation holder for Ivermectin Lotion, 0.5% in United States?
ARBOR PHARMS LLC holds the US marketing authorisation.