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FDA Drug Application 103000 by ALLERGAN

Application Number103000
Application Type Biologic License Application
Sponsor ApplicantALLERGAN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/9/1991N205870000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm175011.htm 8/12/2008
AP012/9/1991N238890000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176360.pdf 11/16/2009
AP012/21/2000S79111004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/botaller122100L.htm 3/11/2004
AP012/21/2000S79121004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/103000BotoxTOC.cfm 3/11/2004
AP04/12/2002S79075000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/botuall041202L.htm 3/11/2004
AP04/12/2002S79085000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/botuall041202LB.pdf 3/11/2004
AP04/12/2002S79105000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080509.htm 3/11/2004
AP07/19/2004S98295050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/biologics/2004/103000_5050ltr.pdf 7/21/2004
AP07/19/2004S101885050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103000s5050lbl.pdf 9/15/2004
AP03/11/2005S       
AP04/14/2005S       
AP03/26/2010S       
AP011/10/2005S       
AP08/17/2006S       
AP09/28/2006S       
AP03/1/2007S       
AP04/26/2007S       
AP06/18/2007S       
AP08/23/2007S       
AP09/6/2007S       
AP03/21/2008S       
AP08/6/2008S       
AP03/9/2010S250505189   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5189lbl.pdf 3/17/2010
AP03/9/2010S250595189   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103000s5189ltr.pdf 3/18/2010
AP03/9/2010S375365189   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/103000Orig1s5189.pdf 10/23/2013
AP08/21/2009S       
AP07/31/2009S231475209   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103000s5209s5210ltr.pdf 8/7/2009
AP07/31/2009S231455209   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103000s5109s5210lbl.pdf 8/7/2009
AP07/31/2009S231465210   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103000s5109s5210lbl.pdf 8/7/2009
AP07/31/2009S231485210   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103000s5209s5210ltr.pdf 8/7/2009
AP010/15/2010S266975215   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103000s5215lbl.pdf 10/19/2010
AP010/15/2010S267115215   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103000s5215ltr.pdf 10/20/2010
AP010/15/2010S367375215   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2010/103000Orig1s5215.pdf 8/9/2013
AP06/3/2010S       
AP08/24/2011S299155232   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdf 8/30/2011
AP08/24/2011S299165232   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103000s5232ltr.pdf 8/30/2011
AP08/24/2011S439755232   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/103000Orig1s5232.pdf 9/23/2015
AP06/23/2011S294585236   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5236lbl.pdf 7/8/2011
AP08/5/2015SLR435915244   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5244lbl.pdf 8/7/2015
AP08/5/2015SLR436015244   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5244ltr.pdf 8/10/2015
AP01/18/2013SE8349285251   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103000Orig1s5251ltr.pdf 1/23/2013
AP01/18/2013SE8349355251   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103000s5251lbl.pdf 1/23/2013
AP01/21/2016SE8450005252   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103000Orig1s5252ltr.pdf 1/22/2016
AP01/21/2016SE8450245252   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103000s5252lbl.pdf 1/26/2016
AP011/9/2012SLR343755253   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103000Orig1s5253ltr.pdf 11/14/2012
AP011/9/2012SLR343765253   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103000Orig1s5253mg.pdf 11/14/2012
AP011/9/2012SLR343775253   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103000Orig1s5253lbl.pdf 11/14/2012
AP07/16/2012SLR332245256   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103000Orig1s5256ltr.pdf 7/18/2012
AP09/11/2013SE8370895260   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103000Orig1s5260ltr.pdf 9/13/2013
AP09/11/2013SE8371225260   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103000s5260lbl.pdf 9/17/2013
AP05/7/2014SLR392505280   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103000Orig1s5280ltr.pdf 5/8/2014
AP04/17/2015SE8425925282   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5282ltr.pdf 4/21/2015
AP04/17/2015SE8426005282   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5282lbl.pdf 4/21/2015
AP08/11/2015SLR436335292   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103000Orig1s5292ltr.pdf 8/12/2015
AP08/11/2015SLR436355292   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103000s5292lbl.pdf 8/12/2015
AP02/4/2016SLR451235294   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103000Orig1s5294ltr.pdf 2/5/2016




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