FDA — authorised 16 February 1999
- Application: NDA020936
- Marketing authorisation holder: APOTEX
- Local brand name: PAXIL CR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Paroxetine CR in United States
FDA authorised Paroxetine CR on 16 February 1999
Marketing authorisation
Other Psychiatry / Neurology approved in United States
Frequently asked questions
Is Paroxetine CR approved in United States?
Yes. FDA authorised it on 16 February 1999.
Who is the marketing authorisation holder for Paroxetine CR in United States?
APOTEX holds the US marketing authorisation.