FDA — authorised 17 March 2010
- Application: ANDA079043
- Marketing authorisation holder: DR REDDYS LABS LTD
- Status: supplemented
FDA authorised Fexofenadine HCL and pseudoephedrine HCL on 17 March 2010
Yes. FDA authorised it on 17 March 2010.
DR REDDYS LABS LTD holds the US marketing authorisation.