FDA — authorised 27 March 1985
- Application: NDA019339
- Marketing authorisation holder: HOSPIRA
- Local brand name: HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Heparin Sodium In Plastic Container in United States
FDA authorised Heparin Sodium In Plastic Container on 27 March 1985
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 29 July 2020
- Application: ANDA203851
- Marketing authorisation holder: PHARMOBEDIENT
- Indication: Labeling
- Status: approved
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.
Frequently asked questions
Is Heparin Sodium In Plastic Container approved in United States?
Yes. FDA authorised it on 27 March 1985; 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?
HOSPIRA holds the US marketing authorisation.