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FDA Drug Application 020632 by ABBOTT

Application Number020632
Application Type New Drug Application
Sponsor ApplicantABBOTT
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
AP011/22/1997N5938000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20632_meridia.cfm 6/17/2003
AP011/22/1997N26349000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM224378.pdf 9/1/2010
AP08/7/1998SCM       
AP08/7/1998SCM19166002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020632_S002_MERIDIA_CAPSULES.pdf 2/19/2008
AP07/6/1999SCP19210004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S004_MERIDA_CAPSULES.pdf 2/19/2008
AP011/12/1999SLR19209006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S006_MERIDIA_CAPSULES.pdf 2/19/2008
AP02/16/2001SE81547008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf 2/16/2001
AP02/16/2001SE81548008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf 2/16/2001
AP02/16/2001SE21549011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf 2/16/2001
AP02/16/2001SE21550011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf 2/16/2001
AP04/25/2002SCM       
AP08/7/2002SCP19206014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S014_MERIDIA.pdf 2/19/2008
AP010/8/2002SCM19205015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S015_MERIDIA.pdf 2/19/2008
AP09/25/2003SLR6716017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20632slr017ltr.pdf 9/30/2003
AP09/25/2003SLR17146017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020632_S017_MERIDIA_AP.pdf 7/9/2007
AP011/24/2004SCP10688019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf 12/2/2004
AP011/24/2004SCP10707019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf 12/3/2004
AP011/24/2004SLR10689020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf 12/2/2004
AP012/8/2005SE513257021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s021lbl.pdf 12/15/2005
AP012/8/2005SE513270021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s021ltr.pdf 12/15/2005
AP012/8/2005SE517208021   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm191652.htm 7/9/2007
AP07/29/2005SLR12499024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s024ltr.pdf 8/3/2005
AP07/29/2005SLR12510024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s024lbl.pdf 8/3/2005
AP08/23/2006SLR14763026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf 8/29/2006
AP08/23/2006SLR14879026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020632s026ltr.pdf 9/18/2006
AP05/29/2008SLR19904030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf 5/30/2008
AP012/24/2008SLR21432031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s031ltr.pdf 12/30/2008
AP012/24/2008SLR21460031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020632s031lbl.pdf 1/2/2009
AP05/4/2009SLR22447032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020632s032ltr.pdf 5/6/2009
AP05/4/2009SLR22478032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf 5/11/2009
AP08/4/2010SLR26167034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf 8/10/2010
AP08/4/2010SLR26169034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf 8/10/2010
AP08/4/2010SLR26191034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf 8/10/2010
AP08/4/2010SLR26168035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf 8/10/2010
AP08/4/2010SLR26170035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf 8/10/2010
AP08/4/2010SLR26192035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf 8/10/2010




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