FDA — authorised 10 April 2007
- Application: ANDA065355
- Marketing authorisation holder: LUPIN PHARMS
- Status: approved
🇺🇸 Suprax in United States
FDA authorised Suprax on 10 April 2007
Marketing authorisations
FDA — authorised 14 April 2015
- Application: ANDA204835
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CEFIXIME
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 October 2018
- Application: ANDA210574
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 19 February 2021
- Application: ANDA211775
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CEFIXIME
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 December 2024
- Application: ANDA206358
- Marketing authorisation holder: FDC LTD
- Local brand name: CEFIXIME
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2025
- Application: NDA203195
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
The FDA approved Suprax, a drug product, for its approved labeling on May 22, 2025. The marketing authorization holder is LUPIN LTD. Suprax was approved through the standard expedited pathway.
FDA — authorised 23 March 2026
- Application: ANDA217607
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
Suprax 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 Suprax approved in United States?
Yes. FDA authorised it on 10 April 2007; FDA authorised it on 14 April 2015; FDA authorised it on 9 October 2018.
Who is the marketing authorisation holder for Suprax in United States?
LUPIN PHARMS holds the US marketing authorisation.