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FDA Drug Application 020235 by PFIZER PHARMS

Application Number020235
Application Type New Drug Application
Sponsor ApplicantPFIZER 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
AP012/30/1993N26656000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229208.pdf 10/13/2010
AP011/14/1994SLR       
AP04/9/1996SCP       
AP05/28/1996SCM       
AP012/9/1996SCM       
AP02/12/1998SCM       
AP09/29/1998SE2926011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20235s11ltr.pdf 9/29/1998
AP09/29/1998SE2927011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020235S011.pdf 9/29/1998
AP09/29/1998SE2928011   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20235s11lbl.pdf 9/29/1998
AP05/15/2000SCM       
AP010/12/2000SE12941015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf 10/12/2000
AP010/12/2000SE12944015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf 10/12/2000
AP010/12/2000SE18531015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-882S2_21-129S5_Neurontin.cfm 5/6/2004
AP07/21/2000SCS       
AP08/16/2000SCM       
AP01/18/2001SCM       
AP02/8/2001SCM       
AP02/8/2001SCM       
AP01/18/2002SCS       
AP01/30/2002SLR2938022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf 1/30/2002
AP08/15/2002SE89259023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20235se8-023,20882se8-009,21129se8-010ltr.pdf 6/10/2004
AP010/24/2002SCM       
AP012/19/2002SCS       
AP02/18/2005SLR11148029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20235s029,20882s015,21129s016ltr.pdf 2/23/2005
AP02/18/2005SLR11172029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf 2/23/2005
AP05/3/2006SLR14055035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035, 020882s021, 021129s020LTR.pdf 5/5/2006
AP03/1/2011SLR28090036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf 3/4/2011
AP03/1/2011SLR28108036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,021129s022ltr.pdf 3/7/2011
AP04/23/2009SLR22345041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf 4/28/2009
AP04/23/2009SLR22383041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020235s041,020882s028ltr.pdf 5/1/2009
AP010/11/2010SLR26626043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf 10/11/2010
AP010/11/2010SLR26661043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,021129s029ltr.pdf 10/13/2010
AP08/10/2011SLR29744050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf 8/11/2011
AP08/10/2011SLR29755050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s050,020882s035,021129s033ltr.pdf 8/12/2011
AP05/1/2013SLR35957054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 5/7/2013
AP05/1/2013SLR36012054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf 5/9/2013
AP05/1/2013SLR35958055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 5/7/2013
AP05/1/2013SLR36013055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf 5/9/2013
AP05/1/2013SLR35959056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 5/7/2013
AP05/1/2013SLR36014056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf 5/9/2013
AP08/18/2014SLR40281057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020235Orig1s057,020882Orig1s041,021129Orig1s039ltr.pdf 8/20/2014
AP08/18/2014SLR40287057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf 8/20/2014
AP09/14/2015SLR43897060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s060,020882s043,021129Orig1s042ltr.pdf 9/17/2015
AP09/14/2015SLR43972060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf 9/23/2015
AP04/21/2015SLR42667061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s061,020882s044,021129s043lbl.pdf 4/27/2015
AP04/21/2015SLR42770061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s061,020882Orig1s044,021129Orig1s043ltr.pdf 5/11/2015




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