FDA — authorised 12 August 2005
- Marketing authorisation holder: MUTUAL PHARM CO INC
- Status: approved
🇺🇸 Qualaquin in United States
FDA authorised Qualaquin on 12 August 2005
Marketing authorisations
FDA — authorised 12 August 2005
- Application: NDA021799
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: QUALAQUIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 March 2014
- Application: ANDA091661
- Marketing authorisation holder: TEVA PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 15 July 2015
- Application: ANDA203729
- Marketing authorisation holder: AMNEAL PHARMS
- Status: approved
FDA — authorised 11 December 2019
- Application: ANDA204372
- Marketing authorisation holder: NOVAST LABS
- Indication: Labeling
- Status: approved
FDA — authorised 29 August 2025
- Application: ANDA203112
- Marketing authorisation holder: LUPIN LTD
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved LUPIN LTD's Qualaquin for manufacturing (CMC) on 2025-08-29. This approval was granted through a standard expedited pathway. The marketing authorisation holder is LUPIN LTD, and the application number is ANDA203112.
Qualaquin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Qualaquin approved in United States?
Yes. FDA authorised it on 12 August 2005; FDA authorised it on 12 August 2005; FDA authorised it on 10 March 2014.
Who is the marketing authorisation holder for Qualaquin in United States?
MUTUAL PHARM CO INC holds the US marketing authorisation.