FDA — authorised 28 December 1988
- Status: approved
🇺🇸 Nimotop in United States
FDA authorised Nimotop on 28 December 1988
Marketing authorisations
FDA — authorised 28 December 1988
- Application: NDA018869
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: NIMOTOP
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 May 2007
- Application: ANDA077811
- Marketing authorisation holder: HERITAGE
- Status: approved
FDA — authorised 17 January 2008
- Application: ANDA076740
- Marketing authorisation holder: BIONPHARMA
- Local brand name: NIMODIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 May 2013
- Application: NDA203340
- Marketing authorisation holder: AZURITY
- Local brand name: NYMALIZE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 April 2014
- Application: ANDA090103
- Marketing authorisation holder: THEPHARMANETWORK LLC
- Local brand name: NIMODIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 July 2015
- Application: ANDA201832
- Marketing authorisation holder: SOFGEN PHARMS
- Local brand name: NIMODIPINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 July 2024
- Application: ANDA216937
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: NIMODIPINE
- Indication: SOLUTION — ORAL
- Status: approved
Nimotop 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 Nimotop approved in United States?
Yes. FDA authorised it on 28 December 1988; FDA authorised it on 28 December 1988; FDA authorised it on 2 May 2007.
Who is the marketing authorisation holder for Nimotop in United States?
Marketing authorisation holder not available in our data.