FDA — authorised 23 January 1952
- Application: NDA008316
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: supplemented
🇺🇸 PRIMAQUINE PHOSPHATE in United States
FDA authorised PRIMAQUINE PHOSPHATE on 23 January 1952
Marketing authorisations
FDA — authorised 9 December 1968
- Application: NDA014860
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2014
- Application: ANDA203924
- Marketing authorisation holder: ALVOGEN
- Local brand name: PRIMAQUINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2014
- Application: ANDA204476
- Marketing authorisation holder: UNICHEM
- Local brand name: PRIMAQUINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2016
- Application: ANDA206043
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: PRIMAQUINE PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
PRIMAQUINE PHOSPHATE 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 PRIMAQUINE PHOSPHATE approved in United States?
Yes. FDA authorised it on 23 January 1952; FDA authorised it on 9 December 1968; FDA authorised it on 3 February 2014.
Who is the marketing authorisation holder for PRIMAQUINE PHOSPHATE in United States?
SANOFI AVENTIS US holds the US marketing authorisation.