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FDA Drug Application 050725 by DR REDDYS LABS INC

Application Number050725
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
AP05/31/1996N       
AP03/19/1997SLR       
AP02/11/1998SLR       
AP02/19/1998SCM15240003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050725_S003_Augmentin_APPROVAL PACKAGE.pdf 10/25/2006
AP04/10/2002SLR8767004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf 5/27/2004
AP04/10/2002SLR15239004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050725_S004_Augmentin_APPROVAL PACKAGE.pdf 10/25/2006
AP02/1/1999SCS15238005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S005_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP09/23/1999SCS15237006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S006_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP011/19/1999SCS15236007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050725_S007_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP06/8/2000SCS15235008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050725_S008_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP05/3/2001SCM15233010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S010_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP011/27/2000SCS15234011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050725_S011_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP03/7/2001SCE       
AP04/17/2001SCS15232013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S013_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP012/7/2001SCE15231014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050725_S014_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP011/27/2002SCF       
AP05/12/2003SLR5854017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf 6/8/2003
AP05/12/2003SLR15230017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S017_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP012/4/2002SCS       
AP010/7/2002SCF       
AP010/17/2002SCS       
AP06/13/2003S15228021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S021_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP012/23/2003S15229022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050725_S023_Augmentin_APPROVAL_PACKAGE.pdf 10/25/2006
AP06/3/2004SLR9079023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf 6/7/2004
AP08/11/2004SLR10001024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf 8/12/2004
AP012/4/2008SLR21330025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf 12/8/2008
AP012/4/2008SLR21345025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf 12/11/2008
AP03/27/2008SLR19537026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf 3/27/2008
AP03/27/2008SLR19573026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf 4/2/2008
AP09/29/2011SLR30172027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050575s039,050597s046,050725s027,050726s021lbl.pdf 9/30/2011
AP09/29/2011SLR30213027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf 10/4/2011
AP01/22/2013SLR34950028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP01/22/2013SLR34962028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34963030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34951030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP09/30/2014SCM       
AP04/17/2015SCM       




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