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FDA Drug Application 050542 by DR REDDYS LABS INC

Application Number050542
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
AP010/21/1980N       
AP012/17/1985SLR       
AP09/12/1988SLR       
AP02/8/1989SCF       
AP04/23/1991SCS       
AP02/27/1998SLR20005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm 2/27/1998
AP04/10/1991SLR       
AP09/13/1993SLR       
AP01/10/1995SLR       
AP02/27/1998SLR63010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm 2/27/1998
AP02/27/1998SE1628011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050542s005s010s011.cfm 2/27/1998
AP02/12/1998SCM       
AP04/10/2002SLR8745016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50542s16ltr.pdf 5/27/2004
AP04/10/2002SLR10158016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-542s016_50-754s001_Amoxil.cfm 9/9/2004
AP05/16/2000SLR10160017   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       
AP05/12/2003SLR5845019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr004,50760slr003,50761slr003ltr.pdf 6/8/2003
AP012/4/2002SCS       
AP012/18/2003SLR7305021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf 12/22/2003
AP07/13/2004SLR9757022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf 7/21/2004
AP01/26/2006SLR       
AP06/9/2008SLR19983024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf 6/12/2008
AP06/9/2008SLR20004024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf 6/13/2008
AP03/28/2008SLR19562025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf 4/1/2008
AP03/28/2008SLR19577025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf 4/2/2008
AP011/16/2011SLR30672026   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
AP011/16/2011SLR30703026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP011/16/2011SLR30673027   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
AP011/16/2011SLR30704027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP011/16/2011SLR30674028   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
AP011/16/2011SLR30702028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP09/24/2015SLR44004029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf 9/28/2015
AP09/24/2015SLR44022029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf 9/29/2015
AP012/3/2015SLR44683030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf 12/8/2015
AP012/3/2015SLR44698030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf 12/8/2015




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