FDA — authorised 27 November 1991
- Application: NDA020076
- Marketing authorisation holder: DR REDDYS LABS SA
- Status: supplemented
🇺🇸 Step 2 in United States
FDA authorised Step 2 on 27 November 1991
Marketing authorisations
FDA — authorised 20 October 1997
- Application: ANDA074612
- Marketing authorisation holder: DIFGEN PHARMS
- Status: supplemented
Other Psychiatry approved in United States
Frequently asked questions
Is Step 2 approved in United States?
Yes. FDA authorised it on 27 November 1991; FDA authorised it on 20 October 1997.
Who is the marketing authorisation holder for Step 2 in United States?
DR REDDYS LABS SA holds the US marketing authorisation.