Back to FDA Applications sponsored by MEDIMETRIKS PHARMS

FDA Drug Application 012787 by MEDIMETRIKS PHARMS

Application Number012787
Application Type New Drug Application
Sponsor ApplicantMEDIMETRIKS PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/15/1963N       
AP06/26/1975SFP       
AP012/12/1975SLR       
AP07/8/1976SLR       
AP01/4/1977SLR       
AP06/4/1977SCM       
AP01/10/1979SLR       
AP09/12/1978SLR       
AP011/28/1978SCS       
AP04/13/1979SCS       
AP07/25/1979SCS       
AP08/13/1979SCM       
AP010/23/1979SCM       
AP02/19/1980SLR       
AP02/19/1980SLR       
AP07/30/1980SCP       
AP06/26/1981SCM       
AP01/19/1981SCP       
AP01/19/1981SCP       
AP01/19/1981SCP       
AP01/19/1981SCP       
AP011/12/1981SCS       
AP011/20/1981SCM       
AP011/19/1982SCM       
AP04/8/1983SPD       
AP09/7/1983SCM       
AP08/29/1984SCM       
AP012/20/1984SCF       
AP04/12/1989SCS       
AP02/10/1989SCS       
AP04/4/1989SCS       
AP02/13/1990SCS       
AP03/6/1995SLR       
AP03/6/1995SLR       
AP04/24/1992SCS       
AP011/13/1992SCS       
AP03/1/1995SLR       
AP07/22/1996SCM       
AP09/26/2000SCM       
AP03/28/2013SCM35620071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf 4/1/2013
AP03/28/2013SCM35660071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf 4/9/2013
AP14/5/2013SCM35620071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf 4/1/2013
AP14/5/2013SCM35660071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf 4/9/2013




Back to FDA Applications sponsored by MEDIMETRIKS PHARMS