FDA — authorised 22 April 2014
- Application: ANDA091673
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 ATAZANAVIR SULFATE in United States
FDA authorised ATAZANAVIR SULFATE on 22 April 2014
Marketing authorisations
FDA — authorised 25 June 2018
- Application: ANDA204806
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 September 2018
- Application: ANDA208177
- Marketing authorisation holder: MYLAN
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 June 2020
- Application: ANDA209717
- Marketing authorisation holder: AMNEAL
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 June 2020
- Application: ANDA210575
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 2021
- Application: ANDA212579
- Marketing authorisation holder: LAURUS
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 February 2022
- Application: ANDA212278
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA200196
- Marketing authorisation holder: EMCURE PHARMS
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA205508
- Marketing authorisation holder: EMCURE PHARMS LTD
- Local brand name: ATAZANAVIR SULFATE; RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA206041
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA091611
- Marketing authorisation holder: MATRIX LABS LTD
- Local brand name: ATAZANAVIR SULFATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA022282
- Marketing authorisation holder: MATRIX LABS LTD
- Local brand name: ATAZANAVIR SULFATE AND RITONAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
ATAZANAVIR SULFATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ATAZANAVIR SULFATE approved in United States?
Yes. FDA authorised it on 22 April 2014; FDA authorised it on 25 June 2018; FDA authorised it on 24 September 2018.
Who is the marketing authorisation holder for ATAZANAVIR SULFATE in United States?
TEVA PHARMS USA holds the US marketing authorisation.