FDA — authorised 31 December 1993
- Application: NDA020261
- Marketing authorisation holder: NOVARTIS
- Local brand name: LESCOL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Lescol in United States
FDA authorised Lescol on 31 December 1993
Marketing authorisations
FDA — authorised 31 December 1993
- Marketing authorisation holder: NOVARTIS
- Status: approved
FDA — authorised 5 November 2015
- Application: NDA021192
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 January 2016
- Application: ANDA079011
- Marketing authorisation holder: TEVA PHARMS USA
- Status: approved
FDA — authorised 5 June 2020
- Application: ANDA078407
- Marketing authorisation holder: TEVA PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 15 September 2020
- Application: ANDA090595
- Marketing authorisation holder: MYLAN PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 26 April 2021
- Application: ANDA209397
- Marketing authorisation holder: BEIJING
- Status: approved
Lescol 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 Lescol approved in United States?
Yes. FDA authorised it on 31 December 1993; FDA authorised it on 31 December 1993; FDA authorised it on 5 November 2015.
Who is the marketing authorisation holder for Lescol in United States?
NOVARTIS holds the US marketing authorisation.