FDA — authorised 8 January 1987
- Application: ANDA070872
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NITROSTAT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Nitrostat in United States
FDA authorised Nitrostat on 8 January 1987
Marketing authorisations
FDA — authorised 1 May 2000
- Application: NDA021134
- Marketing authorisation holder: VIATRIS
- Local brand name: NITROSTAT
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA070863
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NITROSTAT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070871
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NITROSTAT
- Indication: INJECTABLE — INJECTION
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Nitrostat approved in United States?
Yes. FDA authorised it on 8 January 1987; FDA authorised it on 1 May 2000; FDA has authorised it.
Who is the marketing authorisation holder for Nitrostat in United States?
PARKE DAVIS holds the US marketing authorisation.