FDA — authorised 26 September 1996
- Marketing authorisation holder: PAR PHARM INC
- Status: approved
🇺🇸 Accolate in United States
FDA authorised Accolate on 26 September 1996
Marketing authorisations
FDA — authorised 17 August 1998
- Application: NDA020547
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 18 November 2010
- Application: ANDA090372
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: ZAFIRLUKAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 2020
- Application: ANDA212475
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: ZAFIRLUKAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 2022
- Application: ANDA204928
- Marketing authorisation holder: RISING PHARMS
- Local brand name: ZAFIRLUKAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2023
- Application: ANDA213163
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ZAFIRLUKAST
- Indication: TABLET — ORAL
- Status: approved
Accolate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Accolate approved in United States?
Yes. FDA authorised it on 26 September 1996; FDA authorised it on 17 August 1998; FDA authorised it on 18 November 2010.
Who is the marketing authorisation holder for Accolate in United States?
PAR PHARM INC holds the US marketing authorisation.