FDA — authorised 4 November 1959
- Application: NDA012157
- Marketing authorisation holder: BAUSCH
- Local brand name: NORFLEX
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Postop oral orphenadrine in United States
FDA authorised Postop oral orphenadrine on 4 November 1959
Marketing authorisations
FDA — authorised 2 October 1960
- Application: NDA013055
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: NORFLEX
- Indication: INJECTABLE — INJECTION
- Status: approved
Frequently asked questions
Is Postop oral orphenadrine approved in United States?
Yes. FDA authorised it on 4 November 1959; FDA authorised it on 2 October 1960.
Who is the marketing authorisation holder for Postop oral orphenadrine in United States?
BAUSCH holds the US marketing authorisation.