FDA — authorised 14 August 2009
- Application: ANDA078804
- Marketing authorisation holder: BARR
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 aspirin and dipyridamole in United States
FDA authorised aspirin and dipyridamole on 14 August 2009 · 114 US adverse-event reports
Marketing authorisations
FDA — authorised 8 March 2016
- Application: ANDA206392
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 January 2017
- Application: ANDA206739
- Marketing authorisation holder: SANDOZ
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 January 2017
- Application: ANDA206964
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 January 2017
- Application: ANDA207944
- Marketing authorisation holder: PH HEALTH
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 August 2017
- Application: ANDA206753
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 August 2018
- Application: ANDA208572
- Marketing authorisation holder: SUN PHARM
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 October 2018
- Application: ANDA209048
- Marketing authorisation holder: DR REDDYS
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2019
- Application: ANDA204552
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 May 2019
- Application: ANDA210318
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: ASPIRIN AND DIPYRIDAMOLE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 114
Most-reported reactions
- Cerebrovascular Accident — 16 reports (14.04%)
- Nausea — 15 reports (13.16%)
- Vomiting — 14 reports (12.28%)
- Pain In Extremity — 12 reports (10.53%)
- Diarrhoea — 11 reports (9.65%)
- Dizziness — 10 reports (8.77%)
- Fatigue — 10 reports (8.77%)
- Headache — 10 reports (8.77%)
- Drug Interaction — 8 reports (7.02%)
- Transient Ischaemic Attack — 8 reports (7.02%)
aspirin and dipyridamole in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is aspirin and dipyridamole approved in United States?
Yes. FDA authorised it on 14 August 2009; FDA authorised it on 8 March 2016; FDA authorised it on 18 January 2017.
Who is the marketing authorisation holder for aspirin and dipyridamole in United States?
BARR holds the US marketing authorisation.