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FDA Drug Application 050582 by MAYNE PHARMA INTL

Application Number050582
Application Type New Drug Application
Sponsor ApplicantMAYNE PHARMA INTL
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
AP07/22/1985N       
AP09/17/1985SLR       
AP09/12/1985SCE       
AP09/17/1985SCF       
AP09/17/1985SCE       
AP010/2/1985SCF       
AP05/30/1986SCF       
AP08/26/1991SCS       
AP08/26/1991SCF       
AP03/29/1993SCM       
AP09/1/1999SCM       
AP03/15/2001SCS       
AP05/4/2001SCS       
AP08/13/2001SCS       
AP06/18/2002SLR1742016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50582s016ltr.pdf 6/18/2002
AP05/22/2002SCM       
AP010/25/2002SCE       
AP06/5/2003SLR5856021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50582slr021ltr.pdf 6/8/2003
AP02/13/2004SLR7732022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50582slr022ltr.pdf 2/27/2004
AP05/6/2005SLR11628024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050582s024ltr.pdf 5/17/2005
AP05/6/2005SLR11655024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050582s024lbl.pdf 5/17/2005
AP02/7/2008SLR19078027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050582s027ltr.pdf 2/13/2008
AP02/7/2008SLR19113027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050582s027lbl.pdf 2/14/2008
AP03/21/2011SLR28336028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050582s028,050795s013ltr.pdf 3/24/2011
AP09/2/2015SLR43816029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050582s029lbl.pdf 9/4/2015
AP09/2/2015SLR43819029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050582Orig1s029ltr.pdf 9/4/2015




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