FDA — authorised 17 September 1998
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
🇺🇸 Sustiva in United States
FDA authorised Sustiva on 17 September 1998
Marketing authorisations
FDA — authorised 1 February 2002
- Application: NDA021360
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: SUSTIVA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 2018
- Application: ANDA203041
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 3 June 2019
- Application: ANDA206894
- Marketing authorisation holder: CIPLA
- Status: approved
FDA — authorised 14 May 2020
- Application: ANDA213038
- Marketing authorisation holder: LAURUS
- Status: approved
FDA — authorised 24 January 2022
- Application: ANDA203053
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 20 June 2024
- Application: ANDA078064
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
Aurobindo Pharma has been granted marketing authorization by the FDA for Sustiva. This approval was issued on June 20, 2024, under application number ANDA078064. Sustiva is approved for labeling, but the specific local brand name is not reported.
Sustiva 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 Sustiva approved in United States?
Yes. FDA authorised it on 17 September 1998; FDA authorised it on 1 February 2002; FDA authorised it on 4 September 2018.
Who is the marketing authorisation holder for Sustiva in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.