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FDA Drug Application 050726 by DR REDDYS LABS INC

Application Number050726
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       
AP02/19/1998SCM       
AP04/10/2002SLR8768004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf 5/27/2004
AP02/1/1999SCS       
AP09/23/1999SCS       
AP011/19/1999SCS       
AP05/3/2001SCM       
AP03/29/2001SCS       
AP04/17/2001SCS       
AP03/28/2002SCS       
AP05/12/2003SLR5855014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf 6/8/2003
AP012/4/2002SCS       
AP010/17/2002SCS       
AP06/3/2004SLR9080017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf 6/7/2004
AP08/11/2004SLR10002018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf 8/12/2004
AP012/4/2008SLR21331019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf 12/8/2008
AP012/4/2008SLR21346019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf 12/11/2008
AP03/27/2008SLR19536020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf 3/27/2008
AP03/27/2008SLR19572020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf 4/2/2008
AP09/29/2011SLR30214021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf 10/4/2011
AP09/29/2011SLR30343021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050726s021lbl.pdf 10/18/2011
AP01/22/2013SLR34952022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP01/22/2013SLR34964022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34953024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP01/22/2013SLR34965024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013




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