FDA — authorised 11 October 1965
- Marketing authorisation holder: WYETH AYERST
- Status: approved
🇺🇸 Nallpen In Plastic Container in United States
FDA authorised Nallpen In Plastic Container on 11 October 1965
Marketing authorisations
FDA — authorised 31 October 1989
- Application: NDA050655
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: NALLPEN IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2011
- Application: ANDA090002
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Status: approved
FDA — authorised 26 December 2012
- Application: ANDA091614
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Status: approved
FDA — authorised 27 July 2020
- Application: ANDA090005
- Marketing authorisation holder: ISTITUTO BIO ITA SPA
- Indication: Labeling
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA091613
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Indication: Labeling
- Status: approved
Nallpen 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 Nallpen In Plastic Container approved in United States?
Yes. FDA authorised it on 11 October 1965; FDA authorised it on 31 October 1989; FDA authorised it on 30 June 2011.
Who is the marketing authorisation holder for Nallpen In Plastic Container in United States?
WYETH AYERST holds the US marketing authorisation.