FDA — authorised 7 August 1973
- Application: ANDA080808
- Marketing authorisation holder: IMPAX LABS
- Local brand name: PYRILAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 PYRILAMINE MALEATE in United States
FDA authorised PYRILAMINE MALEATE on 7 August 1973
Marketing authorisations
FDA — authorised 29 October 1982
- Application: ANDA085231
- Marketing authorisation holder: WATSON LABS
- Local brand name: PYRILAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
PYRILAMINE MALEATE 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 PYRILAMINE MALEATE approved in United States?
Yes. FDA authorised it on 7 August 1973; FDA authorised it on 29 October 1982; FDA has authorised it.
Who is the marketing authorisation holder for PYRILAMINE MALEATE in United States?
IMPAX LABS holds the US marketing authorisation.