FDA — authorised 14 January 2008
- Application: ANDA076273
- Marketing authorisation holder: DR REDDYS
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Plavix in United States
FDA authorised Plavix on 14 January 2008 · 50,565 US adverse-event reports
Marketing authorisations
FDA — authorised 17 May 2012
- Application: ANDA090494
- Marketing authorisation holder: SUN PHARM
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2012
- Application: ANDA091216
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2012
- Application: ANDA076274
- Marketing authorisation holder: APOTEX INC
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2012
- Application: ANDA090844
- Marketing authorisation holder: TORRENT PHARMS LTD
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2012
- Application: ANDA090540
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2012
- Application: ANDA078004
- Marketing authorisation holder: ACME LABS
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 August 2012
- Application: ANDA202266
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 October 2012
- Application: ANDA201686
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2013
- Application: ANDA202925
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 2014
- Application: ANDA202928
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 2014
- Application: ANDA203751
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2017
- Application: ANDA204359
- Marketing authorisation holder: RISING
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 May 2018
- Application: ANDA206376
- Marketing authorisation holder: PRINSTON INC
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 2023
- Application: ANDA203632
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — 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: 50,565
Most-reported reactions
- Myocardial Infarction — 6,909 reports (13.66%)
- Gastrointestinal Haemorrhage — 6,262 reports (12.38%)
- Dyspnoea — 5,734 reports (11.34%)
- Nausea — 4,979 reports (9.85%)
- Fatigue — 4,884 reports (9.66%)
- Cerebrovascular Accident — 4,624 reports (9.14%)
- Dizziness — 4,426 reports (8.75%)
- Asthenia — 4,319 reports (8.54%)
- Diarrhoea — 4,304 reports (8.51%)
- Drug Ineffective — 4,124 reports (8.16%)
Plavix in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Plavix approved in United States?
Yes. FDA authorised it on 14 January 2008; FDA authorised it on 17 May 2012; FDA authorised it on 17 May 2012.
Who is the marketing authorisation holder for Plavix in United States?
DR REDDYS holds the US marketing authorisation.