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FDA Drug Application 050760 by DR REDDYS LABS INC

Application Number050760
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
AP04/15/1999N4393000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50760ltr.pdf 4/15/1999
AP04/15/1999N4394000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50760lbl.pdf 4/15/1999
AP04/15/1999N11973000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050760_s000_AmoxilTOC.cfm 7/11/2005
AP05/16/2000SLR10162001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-542s017_50-754s002_50-760s001_50-761s001_Amoxil.cfm 9/9/2004
AP04/17/2001SCS       
AP05/12/2003SLR5847003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr004,50760slr003,50761slr003ltr.pdf 6/8/2003
AP04/25/2002SCS       
AP05/1/2002SCE       
AP012/4/2002SCS       
AP012/18/2003SLR7306007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf 12/22/2003
AP07/13/2004SLR9759008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf 7/21/2004
AP01/26/2006SLR13518009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050761s009_050760s009lbl.pdf 1/27/2006
AP01/26/2006SLR13563009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050761s009_050760s009ltr.pdf 1/30/2006
AP06/9/2008SLR19981010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf 6/12/2008
AP06/9/2008SLR20005010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf 6/13/2008
AP03/28/2008SLR19559011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf 4/1/2008
AP03/28/2008SLR19575011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf 4/2/2008
AP011/16/2011SLR30678012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 11/21/2011
AP011/16/2011SLR30709012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP011/16/2011SLR30679013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 11/21/2011
AP011/16/2011SLR30710013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP011/16/2011SLR30680015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf 11/21/2011
AP011/16/2011SLR30708015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP07/30/2014SCM       
AP05/29/2014SCM       
AP09/24/2015SLR44006019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf 9/28/2015
AP09/24/2015SLR44024019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf 9/29/2015
AP012/3/2015SLR44685020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf 12/8/2015
AP012/3/2015SLR44696020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf 12/8/2015




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