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FDA Drug Application 019155 by RANBAXY

Application Number019155
Application Type New Drug Application
Sponsor ApplicantRANBAXY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/24/1985N       
AP08/9/1985SCM       
AP08/9/1985SCS       
AP03/27/1986SLR       
AP06/18/1987SCP       
AP02/19/1988SCS       
AP09/15/1989SCS       
AP011/19/1990SCS       
AP03/26/1992SCM       
AP07/16/1992SCS       
AP02/19/1993SCP       
AP01/4/1995SCF       
AP05/5/1995SCS       
AP05/8/1995SCS       
AP012/8/1997SCS       
AP012/8/1997SCS       
AP05/20/1998SCM       
AP04/29/2004SLR8458019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19155slr019,020ltr.pdf 5/3/2004
AP04/29/2004SLR16991019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019155_S019 & S020_LAC_HYDRIN_LOTION_AP.pdf 7/6/2007
AP04/29/2004SLR16992020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019155_S019 & S020_LAC_HYDRIN_LOTION_AP.pdf 7/6/2007
AP04/29/2004SLR8459020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19155slr019,020ltr.pdf 5/3/2004
AP011/9/2007SLR18423022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019155s022lbl.pdf 11/19/2007
AP011/9/2007SLR18452022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019155s022ltr.pdf 11/19/2007
AP04/2/2013SCM       




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