FDA — authorised 6 December 1961
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
🇺🇸 Persantine in United States
FDA authorised Persantine on 6 December 1961
Marketing authorisations
FDA — authorised 6 December 1961
- Application: NDA012836
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: PERSANTINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 1980
- Application: ANDA087184
- Marketing authorisation holder: BARR
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 February 1982
- Application: ANDA087160
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 1984
- Application: ANDA087716
- Marketing authorisation holder: BARR
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1987
- Application: ANDA087717
- Marketing authorisation holder: BARR LABS
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 1989
- Application: ANDA088999
- Marketing authorisation holder: GLENMARK GENERICS
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 1990
- Application: NDA019817
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: IV PERSANTINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 February 1991
- Application: ANDA089001
- Marketing authorisation holder: GLENMARK GENERICS
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 1991
- Application: ANDA089000
- Marketing authorisation holder: GLENMARK GENERICS
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1992
- Application: ANDA087562
- Marketing authorisation holder: IDT AUSTRALIA LTD
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1992
- Application: ANDA087561
- Marketing authorisation holder: IDT AUSTRALIA LTD
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 1996
- Application: ANDA074521
- Marketing authorisation holder: HIKMA
- Local brand name: DIPYRIDAMOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 November 1997
- Application: ANDA074952
- Marketing authorisation holder: DR REDDYS
- Local brand name: DIPYRIDAMOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 1997
- Application: ANDA074601
- Marketing authorisation holder: HOSPIRA
- Local brand name: DIPYRIDAMOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 April 1998
- Application: ANDA074939
- Marketing authorisation holder: CHARTWELL INJECTABLE
- Local brand name: DIPYRIDAMOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 September 1998
- Application: ANDA074956
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DIPYRIDAMOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 January 2000
- Application: ANDA089427
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2002
- Application: ANDA075769
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: DIPYRIDAMOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 April 2006
- Application: ANDA040542
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2007
- Application: ANDA040733
- Marketing authorisation holder: RISING
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 January 2008
- Application: ANDA040874
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2008
- Application: ANDA040898
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089425
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089426
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DIPYRIDAMOLE
- Indication: TABLET — ORAL
- Status: approved
Persantine 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 Persantine approved in United States?
Yes. FDA authorised it on 6 December 1961; FDA authorised it on 6 December 1961; FDA authorised it on 29 September 1980.
Who is the marketing authorisation holder for Persantine in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.