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FDA Drug Application 050720 by DR REDDYS LABS INC

Application Number050720
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
AP02/13/1996N       
AP05/15/1996SCM10629001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050720s001_Augmentin.cfm 11/22/2004
AP03/19/1997SLR       
AP02/11/1998SLR       
AP010/20/1997SCS10630004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050720s004_Augmentin.cfm 11/22/2004
AP02/11/1998SCM10631005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050720s005_Augmentin.cfm 11/22/2004
AP04/10/2002SLR8766006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf 5/27/2004
AP04/10/2002SLR10641006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s006_Augmentin.cfm 11/22/2004
AP02/1/1999SCS10634007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s007_Augmentin.cfm 11/22/2004
AP09/23/1999SCS10633008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s008_Augmentin.cfm 11/22/2004
AP011/19/1999SCS10632009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050720s009_Augmentin.cfm 11/22/2004
AP05/3/2001SCM10636011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050720s011_Augmentin.cfm 11/22/2004
AP04/17/2001SCS10637012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050720s012_Augmentin.cfm 11/22/2004
AP05/1/2002SCE10640013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s013_Augmentin.cfm 11/22/2004
AP07/25/2003SLR6511015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50564slr043,50720slr015ltr.pdf 8/15/2003
AP07/25/2003SLR10646015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050720s015_Augmentin.cfm 11/22/2004
AP012/4/2002SCS10639016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s016_Augmentin.cfm 11/22/2004
AP010/17/2002SCS10638017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050720s017_Augmentin.cfm 11/22/2004
AP05/27/2004SLR8821018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564slr046,50720slr018ltr.pdf 6/1/2004
AP08/30/2004SLR10119019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564s047,50720s019ltr.pdf 9/3/2004
AP08/5/2005SLR12588021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050564s048,050721s021ltr.pdf 8/11/2005
AP06/9/2008SLR19984022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.pdf 6/12/2008
AP06/9/2008SLR20002022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s049, 050720s022ltr.pdf 6/13/2008
AP012/4/2008SLR21333023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s050lbl.pdf 12/8/2008
AP012/4/2008SLR21342023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s050, 050720s023ltr.pdf 12/11/2008
AP04/7/2008SLR19636024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050720s024ltr.pdf 4/10/2008
AP04/7/2008SLR19672024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050720s024lbl.pdf 4/16/2008
AP09/29/2011SLR30169025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.pdf 9/30/2011
AP09/29/2011SLR30207025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050564s052,050720s025ltr.pdf 10/3/2011
AP01/22/2013SLR34948026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP01/22/2013SLR34960026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34949028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP01/22/2013SLR34961028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP03/28/2014SCM       
AP09/30/2014SCM       




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