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FDA Drug Application 020822 by FOREST LABS

Application Number020822
Application Type New Drug Application
Sponsor ApplicantFOREST LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/17/1998N321000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20822ltr.pdf 7/17/1998
AP07/17/1998N322000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020822a.cfm 7/17/1998
AP07/17/1998N323000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20822lbl.pdf 7/17/1998
AP07/17/1998N23912000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088568.pdf 11/16/2009
AP010/19/1999SCS       
AP08/13/1999SCM       
AP010/21/1999SCP       
AP012/7/1999SCS       
AP012/7/1999SCS       
AP07/13/2000SCS       
AP04/27/2000SCM       
AP06/27/2000SCM       
AP06/27/2001SLR       
AP011/22/2000SCM       
AP05/17/2001SCM       
AP07/10/2001SCM       
AP05/30/2002SCM       
AP011/19/2002SLR2353019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20822slr019,21046slr003ltr.pdf 11/19/2002
AP011/19/2002SLR14121019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020822_s019_CelexaTOC.cfm 5/18/2006
AP04/8/2004SLR8362023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21046slr005,20822slr023ltr.pdf 4/20/2004
AP05/20/2004SLR8649027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20822slr027,21046slr007,21323slr015,21365slr008ltr.pdf 5/26/2004
AP02/18/2005SLR11143029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20822s029,21046s009,21323s020,21365s012ltr.pdf 2/23/2005
AP02/18/2005SLR11176029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020822s29lbl.pdf 2/28/2005
AP08/2/2007SLR17499034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020822s034lbl.pdf 8/3/2007
AP08/2/2007SLR17589034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020822s034, 021046s013, 021323s025, 021365s016ltr.pdf 8/7/2007
AP09/17/2008SLR20848035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020822s035,021046s014,ltr.pdf 9/19/2008
AP09/17/2008SLR20859035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020822s35,021046s14lbl.pdf 9/19/2008
AP01/30/2009SLR21723037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020822s037,021046s015,021323s032,021365s023ltr.pdf 2/3/2009
AP01/30/2009SLR21765037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020822s037,021046s015lbl.pdf 2/4/2009
AP08/12/2011SLR29801038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf 8/16/2011
AP08/12/2011SLR29810038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf 8/17/2011
AP08/12/2011SLR30236038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf 10/11/2011
AP08/12/2011SLR29802040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020822s038s040,021046s016s017lbl.pdf 8/16/2011
AP08/12/2011SLR29811040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020822s038,s040,021046s016,s017ltr.pdf 8/17/2011
AP08/12/2011SLR30237040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf 10/11/2011
AP03/27/2012SLR32267042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf 3/28/2012
AP03/27/2012SLR32284042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822s042,021046s019ltr.pdf 3/29/2012
AP03/27/2012SLR37057042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020822Orig1s042.pdf 9/11/2013
AP012/3/2012SLR34533043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s043lbl.pdf 12/3/2012
AP012/3/2012SLR34552043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020822Org1s043,021046Orig1s020,021323Orig1s040,021365Orig1s030ltr.pdf 12/5/2012
AP06/17/2013SCM       
AP04/16/2014SLR39086045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s045ltr.pdf 4/17/2014
AP04/16/2014SLR39294045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822s045lbl.pdf 5/12/2014
AP07/8/2014SLR39831046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020822Orig1s046,021323Orig1s045,021365Orig1s033ltr.pdf 7/10/2014
AP07/8/2014SLR39907046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020822Orig1s046lbl.pdf 7/21/2014




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