FDA — authorised 10 May 1957
- Status: approved
🇺🇸 Norflex in United States
FDA authorised Norflex on 10 May 1957
Marketing authorisations
FDA — authorised 4 November 1959
- Application: NDA012157
- Marketing authorisation holder: BAUSCH
- Local brand name: NORFLEX
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 October 1960
- Application: NDA013055
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: NORFLEX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 November 1988
- Application: ANDA084779
- Marketing authorisation holder: WATSON LABS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 29 May 1998
- Application: ANDA075141
- Marketing authorisation holder: GALT PHARMS
- Status: approved
FDA — authorised 4 March 2003
- Application: ANDA040463
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 27 April 2009
- Application: ANDA040284
- Marketing authorisation holder: LUPIN
- Indication: Labeling
- Status: approved
FDA — authorised 30 August 2011
- Application: ANDA090585
- Marketing authorisation holder: SAGENT PHARMS
- Status: approved
Norflex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Norflex approved in United States?
Yes. FDA authorised it on 10 May 1957; FDA authorised it on 4 November 1959; FDA authorised it on 2 October 1960.
Who is the marketing authorisation holder for Norflex in United States?
Marketing authorisation holder not available in our data.