FDA — authorised 4 June 2003
- Application: NDA021396
- Marketing authorisation holder: WYETH AYERST
- Local brand name: PREMPRO/PREMPHASE
- Indication: Tablet — Oral
- Status: approved
🇺🇸 PREMPRO/PREMPHASE in United States
FDA authorised PREMPRO/PREMPHASE on 4 June 2003
Marketing authorisations
FDA
- Status: approved
PREMPRO/PREMPHASE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is PREMPRO/PREMPHASE approved in United States?
Yes. FDA authorised it on 4 June 2003; FDA has authorised it.
Who is the marketing authorisation holder for PREMPRO/PREMPHASE in United States?
WYETH AYERST holds the US marketing authorisation.