FDA — authorised 14 January 2008
- Application: ANDA076273
- Marketing authorisation holder: DR REDDYS
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 CLOPIDOGREL BISULFATE in United States
FDA authorised CLOPIDOGREL BISULFATE on 14 January 2008 · 7,359 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: ANDA091023
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2012
- Application: ANDA090625
- Marketing authorisation holder: ANI PHARMS
- 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: ANDA090844
- Marketing authorisation holder: TORRENT PHARMS 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 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: ANDA091216
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2012
- Application: ANDA077665
- Marketing authorisation holder: RISING
- 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 28 May 2013
- Application: ANDA090307
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2013
- Application: ANDA078133
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- 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 15 September 2014
- Application: ANDA204165
- Marketing authorisation holder: SCIEGEN 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 17 July 2020
- Application: ANDA213351
- Marketing authorisation holder: PURACAP LABS BLU
- Local brand name: CLOPIDOGREL BISULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 2023
- Application: ANDA205345
- Marketing authorisation holder: HETERO LABS LTD V
- 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 — authorised 20 September 2024
- Application: ANDA215388
- Marketing authorisation holder: MSN
- 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: 7,359
Most-reported reactions
- Dyspnoea — 924 reports (12.56%)
- Fatigue — 833 reports (11.32%)
- Myocardial Infarction — 833 reports (11.32%)
- Drug Ineffective — 747 reports (10.15%)
- Diarrhoea — 720 reports (9.78%)
- Nausea — 708 reports (9.62%)
- Dizziness — 702 reports (9.54%)
- Anaemia — 662 reports (9%)
- Asthenia — 628 reports (8.53%)
- Off Label Use — 602 reports (8.18%)
CLOPIDOGREL BISULFATE 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 CLOPIDOGREL BISULFATE 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 CLOPIDOGREL BISULFATE in United States?
DR REDDYS holds the US marketing authorisation.