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FDA Drug Application 050754 by DR REDDYS LABS INC

Application Number050754
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
AP07/10/1998N4398000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50754AP.PDF 7/10/1998
AP07/10/1998N8747000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50754.pdf 5/27/2004
AP04/10/2002SLR10159001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-542s016_50-754s001_Amoxil.cfm 9/9/2004
AP04/10/2002SLR8746001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50542s16ltr.pdf 5/27/2004
AP05/16/2000SLR10161002   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       
AP05/12/2003SLR5846004   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       
AP012/18/2003SLR7307008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf 12/22/2003
AP07/13/2004SLR9758009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf 7/21/2004
AP01/26/2006SLR       
AP06/9/2008SLR19982011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf 6/12/2008
AP06/9/2008SLR20003011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf 6/13/2008
AP03/28/2008SLR19561012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf 4/1/2008
AP03/28/2008SLR19578012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf 4/2/2008
AP011/16/2011SLR30675013   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
AP011/16/2011SLR30706013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP011/16/2011SLR30707014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP011/16/2011SLR30676014   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
AP011/16/2011SLR30677017   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
AP011/16/2011SLR30705017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf 11/21/2011
AP09/30/2014SCM       
AP09/24/2015SLR44005019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050754s019ltr.pdf050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf 9/28/2015
AP09/24/2015SLR44023019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf 9/29/2015
AP012/3/2015SLR44684020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf 12/8/2015
AP012/3/2015SLR44697020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf 12/8/2015




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