FDA — authorised 9 February 1939
- Marketing authorisation holder: ORGANON USA INC
- Status: approved
🇺🇸 Heparin Sodium In Plastic Container in United States
FDA authorised Heparin Sodium In Plastic Container on 9 February 1939
Marketing authorisations
FDA — authorised 1 December 1993
- Application: ANDA088100
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 10 June 2016
- Application: ANDA206552
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 18 July 2016
- Application: NDA018916
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 February 2017
- Application: ANDA205323
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 19 December 2024
- Application: NDA214520
- Marketing authorisation holder: CORMEDIX
- Indication: Labeling
- Status: approved
The FDA approved Heparin Sodium In Plastic Container, manufactured by CORMEDIX, on 19 December 2024. This approval was granted under the standard expedited pathway, with the application number NDA214520. The approved indication is for labeling.
Heparin Sodium In Plastic Container 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 Heparin Sodium In Plastic Container approved in United States?
Yes. FDA authorised it on 9 February 1939; FDA authorised it on 1 December 1993; FDA authorised it on 10 June 2016.
Who is the marketing authorisation holder for Heparin Sodium In Plastic Container in United States?
ORGANON USA INC holds the US marketing authorisation.