FDA — authorised 29 March 1993
- Application: NDA020164
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: LOVENOX (PRESERVATIVE FREE)
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Lovenox (Preservative Free) in United States
FDA authorised Lovenox (Preservative Free) on 29 March 1993
Marketing authorisations
FDA — authorised 29 March 1993
- Marketing authorisation holder: SANOFI AVENTIS US
- 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 24 August 2012
- Application: ANDA076684
- Marketing authorisation holder: AMPHASTAR PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 28 December 2015
- Application: ANDA077857
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 12 January 2016
- Application: ANDA076726
- Marketing authorisation holder: ZYDUS PHARMS
- Indication: Labeling
- 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 26 June 2024
- Application: ANDA078990
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
The FDA approved Lovenox (Preservative Free) for labeling indications on June 26, 2024. This approval was granted to GLAND under application number ANDA078990. The approval was made through the standard expedited pathway.
FDA — authorised 7 January 2026
- Application: ANDA218775
- Marketing authorisation holder: HEBEI CHANGSHAN
- Local brand name: ENOXAPARIN SODIUM (PRESERVATIVE FREE)
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
Lovenox (Preservative Free) 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 Lovenox (Preservative Free) approved in United States?
Yes. FDA authorised it on 29 March 1993; FDA authorised it on 29 March 1993; FDA authorised it on 28 November 2011.
Who is the marketing authorisation holder for Lovenox (Preservative Free) in United States?
SANOFI AVENTIS US holds the US marketing authorisation.