FDA — authorised 17 August 1987
- Application: NDA019398
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Labeling
- Status: approved
🇺🇸 L-Isoleucine in United States
FDA authorised L-Isoleucine on 17 August 1987
Marketing authorisations
FDA — authorised 11 July 1994
- Application: NDA020015
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 April 1999
- Application: NDA020678
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 February 2001
- Application: ANDA020512
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 25 July 2002
- Application: NDA020734
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- Status: approved
FDA
- Status: approved
L-Isoleucine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is L-Isoleucine approved in United States?
Yes. FDA authorised it on 17 August 1987; FDA authorised it on 11 July 1994; FDA authorised it on 15 April 1999.
Who is the marketing authorisation holder for L-Isoleucine in United States?
OTSUKA ICU MEDCL holds the US marketing authorisation.