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FDA Drug Application 020869 by OAK PHARMS INC

Application Number020869
Application Type New Drug Application
Sponsor ApplicantOAK PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/7/1998N933000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20869ltr.pdf 4/7/1998
AP04/7/1998N934000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20869lbl.pdf 4/7/1998
AP04/7/1998N6455000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020869_cosopt_toc.cfm 8/8/2003
AP01/4/1999SLR2600001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-869-s-001_cosopt.pdf 1/4/1999
AP011/9/2000SCS       
AP01/23/2000SLR       
AP011/21/2000SCM       
AP08/24/2000SLR       
AP07/19/2001SCS       
AP07/24/2001SCM       
AP012/4/2001SCM       
AP012/4/2001SCM       
AP08/28/2002SCS       
AP04/23/2002SLR2596012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20869s012.pdf 4/23/2002
AP04/23/2002SLR2597012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20869s12lbl.pdf 4/23/2002
AP05/16/2002SCM       
AP012/6/2002SCP       
AP03/28/2005SLR11332020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020869s020ltr.pdf 3/30/2005
AP03/28/2005SLR11333020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s020lbl.pdf 3/30/2005
AP012/9/2005SLR13259022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020869s022lbl.pdf 12/15/2005
AP012/9/2005SLR13275022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020869s022ltr.pdf 12/15/2005
AP04/26/2006SLR14002026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s026s028lbl.pdf 5/1/2006
AP04/26/2006SLR14030026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s026, s028LTR.pdf 5/1/2006
AP04/26/2006SLR14031028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s026, s028LTR.pdf 5/1/2006
AP04/26/2006SLR14003028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s026s028lbl.pdf 5/1/2006
AP08/9/2006SLR14659030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020869s030lbl.pdf 8/11/2006
AP08/9/2006SLR14705030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020869s030LTR.pdf 8/14/2006
AP010/22/2008SLR21076034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020869s034ltr.pdf 10/23/2008
AP010/22/2008SLR21163034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020869s034lbl.pdf 11/7/2008
AP06/18/2010SLR25763036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020869s036ltr.pdf 6/22/2010
AP06/18/2010SLR25789036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020869s036lbl.pdf 6/24/2010
AP07/31/2015SLR43555040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020869Orig1s040ltr.pdf 8/3/2015
AP07/31/2015SLR43566040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020869s040lbl.pdf 8/4/2015




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