FDA — authorised 18 February 2014
- Marketing authorisation holder: LUNDBECK NA LTD
- Status: approved
🇺🇸 Northera in United States
FDA authorised Northera on 18 February 2014
Marketing authorisations
FDA — authorised 3 November 2014
- Application: NDA203202
- Marketing authorisation holder: LUNDBECK NA LTD
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA211652
- Marketing authorisation holder: LUPIN PHARMS
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA213911
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA214384
- Marketing authorisation holder: SUN PHARM
- Status: approved
FDA — authorised 28 April 2021
- Application: ANDA213033
- Marketing authorisation holder: BIONPHARMA
- Status: approved
Northera in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Northera approved in United States?
Yes. FDA authorised it on 18 February 2014; FDA authorised it on 3 November 2014; FDA authorised it on 18 February 2021.
Who is the marketing authorisation holder for Northera in United States?
LUNDBECK NA LTD holds the US marketing authorisation.