FDA — authorised 16 June 1999
- Application: NDA020364
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
🇺🇸 Lotensin in United States
FDA authorised Lotensin on 16 June 1999
Marketing authorisations
FDA — authorised 11 February 2004
- Application: ANDA076342
- Marketing authorisation holder: ANI PHARMS
- Status: approved
FDA — authorised 14 February 2011
- Application: ANDA077183
- Marketing authorisation holder: DR REDDYS LABS INC
- Indication: Labeling
- Status: approved
FDA — authorised 30 June 2015
- Application: ANDA076631
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 7 December 2018
- Application: ANDA077215
- Marketing authorisation holder: AMNEAL
- Status: approved
Lotensin 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 Lotensin approved in United States?
Yes. FDA authorised it on 16 June 1999; FDA authorised it on 11 February 2004; FDA authorised it on 14 February 2011.
Who is the marketing authorisation holder for Lotensin in United States?
SANDOZ holds the US marketing authorisation.