FDA — authorised 2 February 1995
- Marketing authorisation holder: SHIONOGI INC
- Status: approved
🇺🇸 Sular in United States
FDA authorised Sular on 2 February 1995
Marketing authorisations
FDA — authorised 2 February 1995
- Application: NDA020356
- Marketing authorisation holder: AZURITY
- Local brand name: SULAR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 July 2008
- Application: ANDA079051
- Marketing authorisation holder: MYLAN
- Local brand name: NISOLDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 January 2011
- Application: ANDA091001
- Marketing authorisation holder: MYLAN
- Local brand name: NISOLDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 April 2023
- Application: ANDA216606
- Marketing authorisation holder: AMTA
- Local brand name: NISOLDIPINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Sular in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Sular approved in United States?
Yes. FDA authorised it on 2 February 1995; FDA authorised it on 2 February 1995; FDA authorised it on 25 July 2008.
Who is the marketing authorisation holder for Sular in United States?
SHIONOGI INC holds the US marketing authorisation.