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FDA Drug Application 019787 by PFIZER

Application Number019787
Application Type New Drug Application
Sponsor ApplicantPFIZER
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
AP07/31/1992N       
AP01/12/1995SLR6359002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S2_Norvasc Tablets_toc.cfm 8/5/2003
AP03/3/1994SCS6360003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S3_Norvasc_toc.cfm 8/5/2003
AP05/3/1994SCS6361004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S4_Norvasc Tablets_toc.cfm 8/5/2003
AP02/7/1995SCM6362005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S5_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP06/19/1995SCS6363006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S6_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP06/14/1996SE53754007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/19-787s007_Amlodipine.cfm 4/30/2002
AP011/2/1995SCS6364008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S8_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP012/5/1995SLR6365009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S9_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP02/8/1996SCM6366010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S10_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP02/7/1996SCM6367011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S11_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP06/28/1996SCS6368012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S12_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP01/8/1997SLR4324013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19787-S013_Norvasc.pdf 1/8/1997
AP04/18/1997SCS6369014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019787-S14_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP05/16/1997SCM6370015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019787-S15_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP03/9/1998SCS6371016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019787-S16_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP07/12/2000SLR3003017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787-s017_norvase.pdf 7/12/2000
AP07/12/2000SLR1105017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19787S020LTR.PDF 7/12/2000
AP06/4/1999SCM3002018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787-s018_Norvasc.pdf 6/4/1999
AP09/7/1999SCM6372019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019787-S19_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm 8/5/2003
AP09/7/1999SCM9279019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787S019_NORVASC_APPROV.PDF 6/10/2004
AP07/12/2000SE81367020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19787S020LTR.PDF 7/12/2000
AP07/12/2000SE83004020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787-s017_norvase.pdf 7/12/2000
AP02/1/2000SCP3001021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787s021_norvasc.pdf 2/1/2000
AP012/15/1999SCS3000022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787s022_Norvasc.pdf 12/15/1999
AP03/14/2000SLR       
AP09/6/2000SCS       
AP02/23/2000SCM       
AP012/3/2003SLR7054027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19787slr027ltr.pdf 12/8/2003
AP08/10/2001SCM       
AP08/13/2001SCM       
AP01/8/2004SE57497030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19787se5-030ltr.pdf 1/9/2004
AP01/8/2004SE515927030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019787_S30_NorvascTOC.cfm 3/2/2007
AP08/20/2003SLR6547031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19787slr031ltr.pdf 8/28/2003
AP05/28/2002SLR2999032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19787s032ltr.pdf 5/28/2002
AP07/13/2005SLR11986037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s037lbl.pdf 7/15/2005
AP07/13/2005SLR11992037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019787s037ltr.pdf 7/15/2005
AP09/28/2005SE112831038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf 9/30/2005
AP09/28/2005SE112928038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019787s038ltr.pdf 10/20/2005
AP010/31/2007SLR18334042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019787s042lbl.pdf 11/7/2007
AP010/31/2007SLR18366042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019787s042ltr.pdf 11/8/2007
AP02/17/2010SLR24823045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019787s045ltr.pdf 2/22/2010
AP02/17/2010SLR24835045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019787s045lbl.pdf 2/23/2010
AP05/9/2011SLR28748047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s047lbl.pdf 5/9/2011
AP05/9/2011SLR28781047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019787s047ltr.pdf 5/11/2011
AP010/31/2011SLR30467052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019787s052ltr.pdf 11/2/2011
AP010/31/2011SLR30475052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s052lbl.pdf 10/31/2011
AP01/7/2013SLR34852053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s053lbl.pdf 1/7/2013
AP01/7/2013SLR34855053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019787Orig1s053,s054ltr.pdf 1/8/2013
AP01/7/2013SLR34856054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019787Orig1s053,s054ltr.pdf 1/8/2013
AP01/7/2013SLR34853054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s054lbl.pdf 1/7/2013
AP011/16/2012SCM       
AP09/12/2013SCM       
AP07/24/2013SCM       
AP07/28/2014SCM       
AP03/23/2015SLR42268059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019787Orig1s059ltr.pdf 3/25/2015
AP03/23/2015SLR42479059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019787s059lbl.pdf 4/9/2015




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