Back to FDA Applications sponsored by PHARMACIA AND UPJOHN

FDA Drug Application 020597 by PHARMACIA AND UPJOHN

Application Number020597
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
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
AP06/5/1996N       
AP06/23/1998SLR       
AP012/9/1998SCS       
AP07/31/1998SCM31538005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020597Orig1s005Approv.pdf 1/27/2012
AP011/1/1998SCP       
AP03/22/1999SLR       
AP07/16/1999SLR       
AP012/20/2002SE14891010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597SE1-010_Xalatan_lbl.pdf 4/4/2003
AP012/20/2002SE14893010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20597se1-010ltr.pdf 4/4/2003
AP01/24/2000SCM31539011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020597Orig1s011Approv.pdf 1/27/2012
AP010/8/1999SLR       
AP06/2/2000SCM31540013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020597Orig1s013Approv.pdf 1/27/2012
AP012/26/2000SLR       
AP011/9/2000SCP       
AP012/11/2000SCS       
AP08/25/2000SLR       
AP08/8/2001SLR5491019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s19lbl.pdf 4/28/2003
AP04/23/2001SCS       
AP05/14/2001SCP       
AP011/26/2001SCS5492023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20597s23lbl.pdf 4/28/2003
AP06/21/2002SCP       
AP08/26/2002SCP2003025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20597scp025ltr.pdf 8/26/2002
AP08/26/2002SCP2004025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20597s25lbl.pdf 8/26/2002
AP011/15/2002SCM31541026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020597Orig1s026Approv.pdf 1/27/2012
AP07/14/2003SLR6160028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20597scs029,slr028ltr.pdf 7/28/2003
AP07/14/2003SCS6161029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20597scs029,slr028ltr.pdf 7/28/2003
AP08/31/2010SLR26370035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020597s035,s036ltr.pdf 9/7/2010
AP08/31/2010SLR26397035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf 9/7/2010
AP08/31/2010SLR26371036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020597s035,s036ltr.pdf 9/7/2010
AP08/31/2010SLR26398036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020597s035s036lbl.pdf 9/7/2010
AP03/13/2012SLR32111044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020597s044ltr.pdf 3/15/2012
AP03/13/2012SLR32144044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020597s044lbl.pdf 3/16/2012
AP011/25/2014SLR41108045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020597Orig1s045,s048ltr.pdf 11/28/2014
AP011/25/2014SLR41142045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf 12/3/2014
AP03/13/2013SCM35463046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020597s046lbl.pdf 3/15/2013
AP011/25/2014SLR41107048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020597Orig1s045,s048ltr.pdf 11/28/2014
AP011/25/2014SLR41143048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020597s045s048lbl.pdf 12/3/2014
AP04/3/2014SCM       




Back to FDA Applications sponsored by PHARMACIA AND UPJOHN