Back to FDA Applications sponsored by MYLAN PHARMS INC

FDA Drug Application 071297 by MYLAN PHARMS INC

Application Number071297
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/10/1986N       
AP04/13/1987SC       
AP04/13/1987SC       
AP04/8/1988SC       
AP04/8/1988SC       
AP04/19/1988SL       
AP04/26/1989SC       
AP14/20/1989SB       
AP24/26/1989SC       
AP06/12/1989SL       
AP08/16/1989SC       
AP03/31/1994SC       
AP03/31/1994SL       
AP09/29/1993SC       
AP05/28/1993SLI       
AP06/28/1995SL       
AP04/3/1998SC       
AP02/5/1998SC       
AP011/7/2000SL       
AP07/11/2007SLR39969025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/071297Orig1s025ltr.pdf 7/24/2014
AP07/11/2007SLR40072025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/071297Orig1s025lbl.pdf 7/30/2014
AP07/11/2007SLR40073025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/071297Orig1s025MG.pdf 7/30/2014
AP02/20/2008SLR40074026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026MG.pdf 7/30/2014
AP02/20/2008SLR40075026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026lbl.pdf 7/30/2014
AP02/20/2008SLR39968026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/071297Orig1s026ltr.pdf 7/24/2014
AP07/17/2014SLR40418030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071297s030lbl.pdf 9/5/2014




Back to FDA Applications sponsored by MYLAN PHARMS INC