FDA — authorised 17 April 2007
- Application: ANDA077067
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: NIMODIPINE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Nimodipine group in United States
FDA authorised Nimodipine group on 17 April 2007
Marketing authorisations
FDA — authorised 2 May 2007
- Application: ANDA077811
- Marketing authorisation holder: HERITAGE
- Local brand name: NIMODIPINE
- Indication: CAPSULE — ORAL
- 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
FDA — authorised 22 January 2025
- Application: ANDA213409
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: NIMODIPINE
- Indication: SOLUTION — ORAL
- Status: approved
Frequently asked questions
Is Nimodipine group approved in United States?
Yes. FDA authorised it on 17 April 2007; FDA authorised it on 2 May 2007; FDA authorised it on 17 January 2008.
Who is the marketing authorisation holder for Nimodipine group in United States?
SUN PHARM INDS INC holds the US marketing authorisation.