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FDA Drug Application 019430 by MYLAN SPECLT

Application Number019430
Application Type New Drug Application
Sponsor ApplicantMYLAN SPECLT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/22/1987N       
AP03/2/1989SLR       
AP08/3/1995SCS       
AP07/25/1996SCS       
AP01/24/1997SCM       
AP05/25/1999SCM       
AP012/15/1999SCM       
AP011/5/1999SCM       
AP05/11/2000SCM       
AP01/11/2001SCS       
AP08/27/2001SLR5288012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19430s12lbl.pdf 4/15/2003
AP02/20/2002SCS       
AP04/16/2002SCE       
AP06/28/2002SCM       
AP08/21/2002SCS       
AP012/19/2002SCS       
AP012/17/2003SLR7294025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19430slr025ltr.pdf 12/22/2003
AP09/26/2008SLR20904044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019430s044ltr.pdf 10/1/2008
AP09/26/2008SLR20932044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019430s044lbl.pdf 10/3/2008
AP05/19/2009SLR22622047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019430s047ltr.pdf 5/26/2009
AP08/20/2012SLR33534053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf 8/20/2012
AP08/20/2012SLR33535053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019430Orig1s053ltr.pdf 8/22/2012
AP07/23/2013SCM38281054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s054.pdf 1/15/2014
AP09/16/2013SCM38288055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s055.pdf 1/16/2014
AP011/8/2013SCM38289056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s056.pdf 1/16/2014
AP012/13/2013SCM       
AP07/17/2014SLR39903058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430orig1s058ltr.pdf 7/21/2014
AP07/17/2014SLR40067058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/19430Orig1s058lbl.pdf 7/30/2014
AP04/30/2014SLR39191059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430Orig1s059ltr.pdf 5/1/2014
AP04/30/2014SLR39201059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019430s059lbl.pdf 5/2/2014
AP03/3/2016SCM       
AP05/18/2016SLR46073061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019430Orig1s061ltr.pdf 5/20/2016
AP05/18/2016SLR46086061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf 5/20/2016
AP08/15/2016SCM       




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