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FDA Drug Application 050761 by DR REDDYS LABS INC

Application Number050761
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
AP04/15/1999N8742000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50761ltr.pdf 5/27/2004
AP04/15/1999N8743000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50761lbl.pdf 5/27/2004
AP04/15/1999N12493000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050761_s000_AmoxilTOC.cfm 8/2/2005
AP05/16/2000SLR10163001   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       
AP05/12/2003SLR5848003   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       
AP012/18/2003SLR7308007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf 12/22/2003
AP07/13/2004SLR9760008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf 7/21/2004
AP01/26/2006SLR13517009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050761s009_050760s009lbl.pdf 1/27/2006
AP01/26/2006SLR13564009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050761s009_050760s009ltr.pdf 1/30/2006
AP06/9/2008SLR19980010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf 6/12/2008
AP06/9/2008SLR20006010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf 6/13/2008
AP03/28/2008SLR19560011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf 4/1/2008
AP03/28/2008SLR19576011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf 4/2/2008
AP011/16/2011SLR30681012   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
AP011/16/2011SLR30712012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP011/16/2011SLR30713013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP011/16/2011SLR30682013   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
AP011/16/2011SLR30683015   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
AP011/16/2011SLR30711015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP09/24/2015SLR44007016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf 9/28/2015
AP09/24/2015SLR44025016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf 9/29/2015
AP012/3/2015SLR44686017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf 12/8/2015
AP012/3/2015SLR44695017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf 12/8/2015




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