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FDA Drug Application 021351 by ALLERGAN SALES LLC

Application Number021351
Application Type New Drug Application
Sponsor ApplicantALLERGAN SALES LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/26/2003N3958000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021351lbl.pdf 2/26/2003
AP02/26/2003N4257000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021351Orig1s000Approv.pdf 3/10/2003
AP02/26/2003N11365000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-351_Oxytrol.cfm 4/8/2005
AP07/5/2006SLR14429002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021351s002lbl.pdf 7/7/2006
AP07/5/2006SLR14458002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021351s002LTR.pdf 7/13/2006
AP01/31/2011SLR27677005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021351s005lbl.pdf 1/31/2011
AP01/31/2011SLR27698005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021351s005ltr.pdf 2/3/2011
AP07/3/2013SCM       
AP010/10/2012SLR34044008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021351Orig1s008,s009ltr.pdf 10/12/2012
AP010/10/2012SLR34079008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf 10/12/2012
AP010/10/2012SLR34045009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021351Orig1s008,s009ltr.pdf 10/12/2012
AP010/10/2012SLR34080009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf 10/12/2012
AP05/29/2013SCM       
AP03/15/2013SCM       
AP07/10/2013SCM       
AP05/16/2014SCM       
AP07/18/2014SCM       
AP07/10/2015SLR43329016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021351Orig1s016ltr.pdf 7/13/2015
AP07/10/2015SLR43345016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021351s016lbl.pdf 7/13/2015




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