FDA — authorised 15 January 1953
- Application: NDA008303
- Marketing authorisation holder: NOVARTIS
- Local brand name: APRESOLINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Hydralazine/Isorsorbide Dinitrate in United States
FDA authorised Hydralazine/Isorsorbide Dinitrate on 15 January 1953
Marketing authorisations
FDA — authorised 9 November 1959
- Application: NDA012093
- Marketing authorisation holder: BAUSCH
- Local brand name: ISORDIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 December 1980
- Application: NDA012882
- Marketing authorisation holder: WYETH AYERST
- Local brand name: ISORDIL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Other Cardiovascular approved in United States
Frequently asked questions
Is Hydralazine/Isorsorbide Dinitrate approved in United States?
Yes. FDA authorised it on 15 January 1953; FDA authorised it on 9 November 1959; FDA authorised it on 12 December 1980.
Who is the marketing authorisation holder for Hydralazine/Isorsorbide Dinitrate in United States?
NOVARTIS holds the US marketing authorisation.