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FDA Drug Application 020076 by DR REDDYS LABS INC

Application Number020076
Application Type New Drug Application
Sponsor ApplicantDR REDDYS LABS INC
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
AP011/27/1991N       
AP01/6/1992SCP       
AP07/21/1992SCM       
AP07/21/1992SCM       
AP010/6/1994SCM       
AP02/8/1996SCM       
AP07/24/1996SCM       
AP010/6/1995SCP       
AP011/12/1999SE6123011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20076S11LTR.PDF 11/12/1999
AP01/7/1999SE4       
AP010/29/1998SCM       
AP012/3/1999SCM       
AP01/31/2000SCM       
AP011/7/2000SCF       
AP07/12/2002SLR2189020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20076slr020ltr.pdf 7/12/2002
AP07/12/2002SLR2190020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s20lbl.pdf 7/12/2002
AP07/15/2002SLR2187021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20076slr021ltr.pdf 7/15/2002
AP07/15/2002SLR2188021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s21lbl.pdf 7/15/2002
AP02/6/2004SLR7794024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076slr024ltr.pdf 3/3/2004
AP01/21/2004SLR7581025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076slr025ltr.pdf 1/22/2004
AP010/21/2004SCP10475027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076s027ltr.pdf 10/29/2004
AP011/22/2005SLR13152028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020076s028ltr.pdf 11/30/2005
AP05/5/2006SLR14113029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020076s029ltr.pdf 5/16/2006
AP05/16/2013SCM       
AP07/25/2014SLR40021036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020076Orig1s036ltr.pdf 7/28/2014
AP07/25/2014SLR40046036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf 7/29/2014
AP011/17/2015SCM       
AP01/19/2016SCM       
AP04/4/2016SCM       
AP05/9/2016SCM       
AP05/10/2016SLR46032041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s041ltr.pdf 5/16/2016
AP05/10/2016SLR46343041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20076Orig1s041Lbl.pdf 6/17/2016
AP07/6/2016SLR46471042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s042ltr.pdf 7/7/2016
AP07/6/2016SLR46483042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s042lbl.pdf 7/8/2016
AP07/5/2016SLR46541043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s043lbl.pdf 7/18/2016
AP07/5/2016SLR46472043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s043ltr.pdf 7/7/2016
AP09/22/2016SCM       




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