FDA — authorised 23 July 2010
- Application: ANDA077857
- Marketing authorisation holder: SANDOZ
- Local brand name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Enoxaparin in United States
FDA authorised Enoxaparin on 23 July 2010 · 18,888 US adverse-event reports
Marketing authorisations
FDA — authorised 19 September 2011
- Application: ANDA076684
- Marketing authorisation holder: AMPHASTAR PHARM
- Local brand name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 28 November 2011
- Application: ANDA078660
- Marketing authorisation holder: SANDOZ INC
- Local brand name: ENOXAPARIN SODIUM
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 23 June 2014
- Application: ANDA076726
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 28 September 2018
- Application: ANDA078990
- Marketing authorisation holder: GLAND
- Local brand name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 March 2019
- Application: ANDA208600
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Local brand name: ENOXAPARIN SODIUM
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 29 November 2019
- Application: ANDA206834
- Marketing authorisation holder: EMERGE BIOSCIENCE
- Local brand name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 June 2022
- Application: ANDA214856
- Marketing authorisation holder: EMERGE BIOSCIENCE
- Local brand name: ENOXAPARIN SODIUM
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 15 March 2023
- Application: ANDA205660
- Marketing authorisation holder: SHENZHEN TECHDOW
- Local brand name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 6 June 2023
- Application: ANDA214646
- Marketing authorisation holder: BE PHARMS
- Status: approved
FDA — authorised 7 January 2026
- Application: ANDA218775
- Marketing authorisation holder: HEBEI CHANGSHAN
- Local brand name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
- Indication: INJECTABLE — SUBCUTANEOUS
- 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: 28 March 2025 – 28 March 2026
- Total reports: 18,888
Most-reported reactions
- Off Label Use — 3,069 reports (16.25%)
- Dyspnoea — 2,144 reports (11.35%)
- Pyrexia — 1,992 reports (10.55%)
- Nausea — 1,967 reports (10.41%)
- Diarrhoea — 1,882 reports (9.96%)
- Anaemia — 1,644 reports (8.7%)
- Vomiting — 1,605 reports (8.5%)
- Fatigue — 1,583 reports (8.38%)
- Pneumonia — 1,556 reports (8.24%)
- Acute Kidney Injury — 1,446 reports (7.66%)
Enoxaparin 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 Enoxaparin approved in United States?
Yes. FDA authorised it on 23 July 2010; FDA authorised it on 19 September 2011; FDA authorised it on 28 November 2011.
Who is the marketing authorisation holder for Enoxaparin in United States?
SANDOZ holds the US marketing authorisation.