FDA — authorised 18 February 2021
- Application: ANDA211818
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Northera in United States
FDA authorised Northera on 18 February 2021
Marketing authorisations
FDA — authorised 18 February 2021
- Application: ANDA213911
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA213162
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA211726
- Marketing authorisation holder: ANNORA
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA214384
- Marketing authorisation holder: SUN PHARM
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA214387
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA214391
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA211741
- Marketing authorisation holder: MSN PHARMS INC
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA214017
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA212835
- Marketing authorisation holder: HIKMA
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2021
- Application: ANDA213661
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 May 2021
- Application: ANDA214543
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 November 2021
- Application: ANDA215265
- Marketing authorisation holder: ADAPTIS
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 May 2022
- Application: ANDA214217
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DROXIDOPA
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- 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 Neuroscience approved in United States
Frequently asked questions
Is Northera approved in United States?
Yes. FDA authorised it on 18 February 2021; FDA authorised it on 18 February 2021; FDA authorised it on 18 February 2021.
Who is the marketing authorisation holder for Northera in United States?
ZYDUS PHARMS holds the US marketing authorisation.