FDA — authorised 24 October 2014
- Application: ANDA204154
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Status: approved
🇺🇸 Stromectol in United States
FDA authorised Stromectol on 24 October 2014
Marketing authorisations
FDA — authorised 13 September 2019
- Application: ANDA210019
- Marketing authorisation holder: TEVA PHARMS USA
- 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 27 October 2020
- Application: NDA202736
- Marketing authorisation holder: ARBOR PHARMS LLC
- Indication: Efficacy
- 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 6 March 2024
- Application: ANDA210225
- Marketing authorisation holder: PADAGIS ISRAEL
- Indication: Labeling
- Status: approved
The FDA approved the marketing authorisation for Stromectol on 6 March 2024, under application number ANDA210225. This approval was granted to PADAGIS ISRAEL. The approved indication for Stromectol is for its labelling, but the specific local brand name is not reported. The approval was processed under the standard expedited pathway.
FDA — authorised 16 October 2024
- Application: ANDA218324
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: IVERMECTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2025
- Application: ANDA215922
- Marketing authorisation holder: RUBICON RESEARCH
- 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
The FDA approved Stromectol (Ivermectin) tablets for oral administration, manufactured by ZYDUS LIFESCIENCES, on 26 February 2026. This approval was granted through the standard expedited pathway. The approved indication for Stromectol is not specified in the provided information, but it is mentioned as TABLET — ORAL. The application number for this approval is ANDA216863.
FDA — authorised 7 April 2026
- Application: ANDA218509
- Marketing authorisation holder: AJANTA PHARMA LTD
- Status: approved
Stromectol 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 Stromectol approved in United States?
Yes. FDA authorised it on 24 October 2014; FDA authorised it on 13 September 2019; FDA authorised it on 6 May 2020.
Who is the marketing authorisation holder for Stromectol in United States?
EDENBRIDGE PHARMS holds the US marketing authorisation.