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FDA Drug Application 050755 by DR REDDYS LABS INC

Application Number050755
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
AP06/22/2001N8769000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin.cfm 5/27/2004
AP06/22/2001N4574000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50755ltr.pdf 6/26/2001
AP06/22/2001N4575000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50755_Augmentin_prntlbl.pdf 6/26/2001
AP011/27/2002SCF       
AP05/12/2003SLR5857003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50755slr003ltr.pdf 6/8/2003
AP05/12/2003SLR11894003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/50-755s003_AugmentinTOC.cfm 6/27/2005
AP012/4/2002SCS       
AP010/17/2002SCS       
AP06/3/2004SLR11084010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050755_S010.pdf 2/4/2005
AP06/3/2004SLR9072010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755slr010ltr.pdf 6/7/2004
AP06/3/2004SLR9845010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50-755010lbl.pdf 7/27/2004
AP011/10/2004SLR10599011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s011ltr.pdf 11/16/2004
AP012/17/2004SE510844012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50755s012ltr.pdf 12/30/2004
AP012/17/2004SE510884012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50755s012lbl.pdf 12/30/2004
AP01/16/2009SLR21652014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050755s014lbl.pdf 1/16/2009
AP01/16/2009SLR21678014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050755s014ltr.pdf 1/26/2009
AP04/17/2008SLR19698015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050755s015ltr.pdf 4/22/2008
AP08/26/2011SLR29923016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf 8/30/2011
AP08/26/2011SLR29930016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf 8/31/2011
AP08/26/2011SLR29931018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf 8/31/2011
AP08/26/2011SLR29924018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050755s016s018lbl.pdf 8/30/2011
AP04/8/2014SCM       
AP09/30/2014SCM       
AP03/16/2015SLR42154022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050755Orig1s022ltr.pdf 3/17/2015
AP03/16/2015SLR42201022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050755s022lbl.pdf 3/19/2015




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